The following data is part of a premarket notification filed by Genmark Diagnostics, Inc with the FDA for Esensor Warfarin Sensitivity Saliva Test.
| Device ID | K110786 |
| 510k Number | K110786 |
| Device Name: | ESENSOR WARFARIN SENSITIVITY SALIVA TEST |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | GENMARK DIAGNOSTICS, INC 5964 LA PLACE COURT SUITE 100 Carlsbad, CA 92008 |
| Contact | John Riolo |
| Correspondent | John Riolo GENMARK DIAGNOSTICS, INC 5964 LA PLACE COURT SUITE 100 Carlsbad, CA 92008 |
| Product Code | NSU |
| Subsequent Product Code | ODV |
| Subsequent Product Code | ODW |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-12-02 |
| Summary: | summary |