510(k) K152612
- Device
- ESensor Warfarin Sensitivity Saliva Test
- Applicant
- GENMARK DIAGNOSTICS, INCORPORATED
- 510(k) number
- K152612
- Product code
- ODW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-26
- Date received
- 2015-09-14
- Regulation
- 862.3360
- Classification name
- Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN MADERAZO
- Address
- 5964 La Pl. Ct. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3005406097
Source Documents#
Other 510(k) Records For Product Code ODW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | 2019-05-24 |
| K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT | Trimgen Corporation | 2009-02-06 |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Osmetech Molecular Diagnostics | 2008-07-17 |
| K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | Autogenomics, Incorporated | 2008-01-23 |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | Nanosphere, Inc. | 2007-09-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary