The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Esensor Warfarin Sensitivity Saliva Test.
| Device ID | K152612 |
| 510k Number | K152612 |
| Device Name: | ESensor Warfarin Sensitivity Saliva Test |
| Classification | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Applicant | GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT Carlsbad, CA 92008 |
| Contact | Alan Maderazo |
| Correspondent | Alan Maderazo GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT Carlsbad, CA 92008 |
| Product Code | ODW |
| Subsequent Product Code | NSU |
| Subsequent Product Code | ODV |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2016-05-26 |
| Summary: | summary |