510(k) K981425 ยท GKF Instrument, Hematocrit, Automated
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981425
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.