FDA 510(k) Applications for Medical Device Product Code "ODW"
(Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K183530 | Akonni Biosystems Inc. | TruDiagnosis System | 05/24/2019 |
| K073014 | AUTOGENOMICS, INCORPORATED | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | 01/23/2008 |
| K152612 | GENMARK DIAGNOSTICS, INCORPORATED | eSensor Warfarin Sensitivity Saliva Test | 05/26/2016 |
| K070804 | NANOSPHERE, INC | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | 09/17/2007 |
| K073720 | OSMETECH MOLECULAR DIAGNOSTICS | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | 07/17/2008 |
| K073071 | TRIMGEN CORPORATION | EQ-PRC LC WARFARIN GENOTYPING KIT | 02/06/2009 |
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