510(k) K942050 ยท GJT Plasma, Coagulation Factor Deficient
HEMOLAB COFAC IX
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, May 19, 1995 |
| Received | Apr 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942050
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.