Panels › Clinical Toxicology › Product code ODW · Class 2
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Regulation 862.3360
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ODW
| Company | 510(k)s | Recalls |
|---|---|---|
| Nanosphere, Inc. | 1 | 1 |
| Akonni Biosystems, Inc. | 1 | 0 |
| Autogenomics, Incorporated | 1 | 0 |
| Genmark Diagnostics, Incorporated | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Trimgen Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2019 | K183530 | TruDiagnosis System Akonni Biosystems, Inc. | ODW |
| May 26, 2016 | K152612 | eSensor Warfarin Sensitivity Saliva Test Genmark Diagnostics, Incorporated | ODW |
| Feb 6, 2009 | K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT Trimgen Corporation | ODW |
| Jul 17, 2008 | K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT Osmetech Molecular Diagnostics | ODW |
| Jan 23, 2008 | K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN Autogenomics, Incorporated | ODW |
| Sep 17, 2007 | K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST Nanosphere, Inc. | ODW |
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