510(k) K110786 ยท NSU Instrumentation For Clinical Multiplex Test Systems
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
| Applicant | GenMark Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 2, 2011 |
| Received | Mar 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110786
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.