510(k) K931992 ยท GKP Instrument, Coagulation, Automated
HEMOLAB
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 22, 1994 |
| Received | Apr 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931992
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.