510(k) K935851 ยท GJT Plasma, Coagulation Factor Deficient
BIOMERIEUX HEMOLAB COFAC X
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jan 17, 1995 |
| Received | Dec 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935851
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.