doc_id stringclasses 201
values | file_name stringclasses 100
values | key stringclasses 15
values | value stringlengths 1 1.66k | text stringlengths 2.2k 9.79k |
|---|---|---|---|---|
idK151917_s0_e2000 | K151917.txt | product code | OOI – Real-time nucleic acid amplification | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex... |
idK151917_s0_e2000 | K151917.txt | panel | Chemistry (75) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Lumine... |
idK151917_s0_e2000 | K151917.txt | predicate device name | BD Diagnostics (Becton, Dickinson and Company), BD MAX System | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex Corp... |
idK151917_s0_e2000 | K151917.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex ... |
idK151917_s0_e2000 | K151917.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Lumine... |
idK151917_s0_e2000 | K151917.txt | applicant | Luminex Corporation | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex... |
idK151917_s0_e2000 | K151917.txt | regulation section | 21 CFR 862.2570 Instrumentation for clinical multiplex test systems | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex ... |
idK193393_s0_e2000 | K193393.txt | purpose for submission | Leica Biosystems Newcastle Ltd., is submitting this traditional 510(k) notification to request modifications to their BOND™ Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Concentrated Liquid Mouse Monoclonal Antibody (Novocastra™), previously cleared under K062615, K171753 and K183102 for the BOND-M... | New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Receptor (16)... |
idK193393_s0_e2000 | K193393.txt | measurand | Human Progesterone Receptor in formalin-fixed, paraffin embedded breast cancer tissue. | New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Receptor (16)... |
idK193393_s0_e2000 | K193393.txt | type of test | Immunohistochemistry (IHC) | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Receptor (1... |
idK193393_s0_e2000 | K193393.txt | classification | Class II | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Recepto... |
idK193393_s0_e2000 | K193393.txt | product code | MXZ | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Recepto... |
idK193393_s0_e2000 | K193393.txt | panel | Immunohistochemistry (IHC) | Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Proge... |
idK193393_s0_e2000 | K193393.txt | intended use | See Indications for Use below. | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Receptor (1... |
idK193393_s0_e2000 | K193393.txt | applicant | Leica Biosystems Newcastle Ltd. | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Recepto... |
idK193393_s0_e2000 | K193393.txt | regulation section | 21 CFR 864.1860 - Immunohistochemistry Reagents and Kits | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I. Background Information: A. 510(k) Number K193393 B. Applicant Leica Biosystems Newcastle Ltd. C. Proprietary and Established Names BOND Ready-to-Use Primary Antibody Progesterone Receptor (1... |
idK193393_s2000_e4000 | K193393.txt | predicate device name | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | ient 00:00 22 Hematoxylin Ambient 05:00 23 Deionized Water Ambient 00:00 24 BOND Wash Solution Ambient 00:00 25 Deionized Water Ambient 00:00 C. Instrument Description Information: Modes of Operation Yes No Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Does... |
idK193393_s6000_e8000 | K193393.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | [93.3%-97.3%] ANA 174 184 94.6% [92.0%-96.7%] AOA 384 404 95.0% [92.8%-97.0%] Pathologist 2 vs 3 APA 196 211 92.9% [90.2%-95.3%] ANA 178 193 92.2% [89.2%-94.8%] AOA 37... |
idK193393_s6000_e8000 | K193393.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 5% [93.3%-97.3%] ANA 174 184 94.6% [92.0%-96.7%] AOA 384 404 95.0% [92.8%-97.0%] Pathologist 2 vs 3 APA 196 211 92.9% [90.2%-95.3%] ANA 178 193 92.2% [89.2%-94.8%] AOA ... |
idK173202_s0_e2000 | K173202.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Coagp... |
idK173202_s0_e2000 | K173202.txt | measurand | Antithrombin activity (%) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Coagp... |
idK173202_s0_e2000 | K173202.txt | type of test | Quantitative chromogenic test | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Coag... |
idK173202_s0_e2000 | K173202.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Coa... |
idK173202_s0_e2000 | K173202.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Co... |
idK173202_s0_e2000 | K173202.txt | applicant | Sekisui Medical Co., LTD | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K173202 B. Purpose for Submission: New device C. Measurand: Antithrombin activity (%) D. Type of Test: Quantitative chromogenic test E. Applicant: Sekisui Medical Co., LTD F. Proprietary and Established Names: CP3000 Coagulation Analyzer Coa... |
idK173202_s6000_e8000 | K173202.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK173202_s6000_e8000 | K173202.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182357_s0_e2000 | K182357.txt | purpose for submission | To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test D... |
idK182357_s0_e2000 | K182357.txt | measurand | Eravacycline 20µg | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test D... |
idK182357_s0_e2000 | K182357.txt | type of test | Antimicrobial Susceptibility Test Disks | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test ... |
idK182357_s0_e2000 | K182357.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test... |
idK182357_s0_e2000 | K182357.txt | product code | JTN | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test... |
idK182357_s0_e2000 | K182357.txt | panel | 83, Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Tes... |
idK182357_s0_e2000 | K182357.txt | intended use | HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomona... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test ... |
idK182357_s0_e2000 | K182357.txt | predicate device name | HardyDisk Tigecycline 15µg | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test D... |
idK182357_s0_e2000 | K182357.txt | applicant | Hardy Diagnostics | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test... |
idK182357_s0_e2000 | K182357.txt | proprietary and established names | HardyDisk AST Eravacycline 20µg (ERV20) | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test Disks E... |
idK182357_s0_e2000 | K182357.txt | regulation section | 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K182357 B. Purpose for Submission: To obtain a susbstantial equivalence determination for Eravacycline Antimicrobial Susceptibility Test Disk C. Measurand: Eravacycline 20µg D. Type of Test: Antimicrobial Susceptibility Test ... |
idK182357_s2000_e4000 | K182357.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK182357_s2000_e4000 | K182357.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK171770_s0_e2000 | K171770.txt | purpose for submission | To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridium... |
idK171770_s0_e2000 | K171770.txt | measurand | tcdB gene of toxigenic Clostridium difficile | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridium... |
idK171770_s0_e2000 | K171770.txt | type of test | Real-time PCR assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridiu... |
idK171770_s0_e2000 | K171770.txt | classification | II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridi... |
idK171770_s0_e2000 | K171770.txt | product code | OZN, OOI | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridi... |
idK171770_s0_e2000 | K171770.txt | panel | Microbiology (83) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostrid... |
idK171770_s0_e2000 | K171770.txt | intended use | The cobas Cdiff Nucleic acid test for use on the cobas Liat System is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from pa... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridiu... |
idK171770_s0_e2000 | K171770.txt | predicate device name | cobas Cdiff Test for use on the cobas 4800 System | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridium... |
idK171770_s0_e2000 | K171770.txt | applicant | Roche Molecular Systems, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridi... |
idK171770_s0_e2000 | K171770.txt | proprietary and established names | cobas Cdiff Nucleic acid test for use on the cobas Liat System | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridium diffi... |
idK171770_s0_e2000 | K171770.txt | regulation section | 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171770 B. Purpose for Submission: To obtain a substantial equivalence determination for the cobas Cdiff Nucleic acid test for use on the cobas Liat System C. Measurand: tcdB gene of toxigenic Clostridiu... |
idK171770_s6000_e8000 | K171770.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK171770_s6000_e8000 | K171770.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK152495_s0_e2000 | K152495.txt | purpose for submission | Addition of an over-the-counter (OTC) claim | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Type o... |
idK152495_s0_e2000 | K152495.txt | measurand | Propoxyphene | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Type o... |
idK152495_s0_e2000 | K152495.txt | type of test | Qualitative immunochromatographic assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Ty... |
idK152495_s0_e2000 | K152495.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. T... |
idK152495_s0_e2000 | K152495.txt | product code | JXN | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. T... |
idK152495_s0_e2000 | K152495.txt | panel | Toxicology, 91 | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. ... |
idK152495_s0_e2000 | K152495.txt | intended use | See Indications for Use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Ty... |
idK152495_s0_e2000 | K152495.txt | predicate device name | Wondfo Propoxyphene Urine Test | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Type o... |
idK152495_s0_e2000 | K152495.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Ty... |
idK152495_s0_e2000 | K152495.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. ... |
idK152495_s0_e2000 | K152495.txt | applicant | Guangzhou Wondfo Biotech Co., Ltd. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. T... |
idK152495_s0_e2000 | K152495.txt | proprietary and established names | Wondfo Propoxyphene Urine Test | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Type of Tes... |
idK152495_s0_e2000 | K152495.txt | regulation section | 21 CFR §862.3700 | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k152495 B. Purpose for Submission: Addition of an over-the-counter (OTC) claim C. Measurand: Propoxyphene D. Ty... |
idK162705_s0_e2000 | K162705.txt | purpose for submission | To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type o... |
idK162705_s0_e2000 | K162705.txt | measurand | D-dimer | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type o... |
idK162705_s0_e2000 | K162705.txt | type of test | Quantitative | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type... |
idK162705_s0_e2000 | K162705.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. ... |
idK162705_s0_e2000 | K162705.txt | product code | GGN, Plasma, Coagulation Control | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. ... |
idK162705_s0_e2000 | K162705.txt | panel | Hematology (81) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D.... |
idK162705_s0_e2000 | K162705.txt | predicate device name | VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type o... |
idK162705_s0_e2000 | K162705.txt | applicant | Maine Standards Company LLC | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. ... |
idK162705_s0_e2000 | K162705.txt | proprietary and established names | VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit | EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type of Test... |
idK162705_s0_e2000 | K162705.txt | regulation section | 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162705 B. Purpose for Submission: To expand the use of previously cleared VALIDATE® D-Dimer Calibration Verification/Linearity Test Kit to the Diagnostica Stago STA-R® Evolution in combination with STA® - Liatest® D-Di. C. Measurand: D-dimer D. Type... |
idK162705_s2000_e4000 | K162705.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK162705_s2000_e4000 | K162705.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143467_s0_e2000 | K143467.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydrogena... |
idK143467_s0_e2000 | K143467.txt | measurand | Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydrogena... |
idK143467_s0_e2000 | K143467.txt | type of test | Quantitative amperometric assay, glucose dehydrogenase (GDH-FAD) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydro... |
idK143467_s0_e2000 | K143467.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydr... |
idK143467_s0_e2000 | K143467.txt | panel | Clinical Chemistry (75) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehyd... |
idK143467_s0_e2000 | K143467.txt | intended use | See Indications for Use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydro... |
idK143467_s0_e2000 | K143467.txt | predicate device name | FORA GD40 Blood Glucose Monitoring System | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydrogena... |
idK143467_s0_e2000 | K143467.txt | applicant | TaiDoc Technology Corporation | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydr... |
idK143467_s0_e2000 | K143467.txt | proprietary and established names | FORA GD43 Blood Glucose Monitoring System | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydrogenase (G... |
idK143467_s0_e2000 | K143467.txt | regulation section | 21 CFR 862.1345, Glucose test system | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143467 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip, palm, forearm, and upper arm D. Type of Test: Quantitative amperometric assay, glucose dehydro... |
idK143467_s4000_e6000 | K143467.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK143467_s4000_e6000 | K143467.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK180886_s0_e2000 | K180886.txt | purpose for submission | To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 μ... |
idK180886_s0_e2000 | K180886.txt | measurand | Delafloxacin 0.002-32 μg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 μ... |
idK180886_s0_e2000 | K180886.txt | type of test | Quantitative Antimicrobial Susceptibility Test growth based detection | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 ... |
idK180886_s0_e2000 | K180886.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32... |
idK180886_s0_e2000 | K180886.txt | product code | JWY - Manual Antimicrobial Susceptibility Test Systems | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32... |
idK180886_s0_e2000 | K180886.txt | panel | 83 – Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-3... |
idK180886_s0_e2000 | K180886.txt | predicate device name | Liofilchem MTS, vancomycin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 μ... |
idK180886_s0_e2000 | K180886.txt | applicant | Liofilchem s.r.l. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32... |
idK180886_s0_e2000 | K180886.txt | proprietary and established names | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002-32 μg/mL | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 μg/mL D... |
idK180886_s0_e2000 | K180886.txt | regulation section | 866.1640 Antimicrobial Susceptibility Test Powder | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180886 B. Purpose for Submission: To obtain a substantial equivalence for the addition of Delafloxacin at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram negative organisms C. Measurand: Delafloxacin 0.002-32 ... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.