510(k) K152612 ยท ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
eSensor Warfarin Sensitivity Saliva Test
| Applicant | Genmark Diagnostics, Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, May 26, 2016 |
| Received | Sep 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152612
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.