510(k) K920001 ยท GFI Osteotome, Manual
HEMOLAB SILIMAT REAGENT
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 25, 1992 |
| Received | Jan 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920001
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.