510(k) K885035 ยท GKP Instrument, Coagulation, Automated
KOAGULAB* 32-S COAGULATION SYSTEM
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 3, 1989 |
| Received | Dec 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885035
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.