INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
FDA 510(k) clearance K073014 · decided 2008-01-23
Clearance details
- K-number
- K073014
- Device name
- INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
- Applicant
- Autogenomics, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2007-10-25
- Decision date
- 2008-01-23
- Days to decision
- 90 days
- Clearance type
- Abbreviated
- Product code
- ODW
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TruDiagnosis System (K183530) | Akonni Biosystems, Inc. | 2019-05-24 |
| eSensor Warfarin Sensitivity Saliva Test (K152612) | Genmark Diagnostics, Incorporated | 2016-05-26 |
| EQ-PRC LC WARFARIN GENOTYPING KIT (K073071) | Trimgen Corporation | 2009-02-06 |
| ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (K073720) | Osmetech Molecular Diagnostics | 2008-07-17 |
| VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (K070804) | Nanosphere, Inc. | 2007-09-17 |
Recalls involving this device
No recalls on record reference this clearance.