510(k) K925493 ยท GJA Test, Thrombin Time
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 21, 1994 |
| Received | Nov 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925493
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.