510(k) K962857 ยท GKP Instrument, Coagulation, Automated
COAG-A-MATE MTX
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Jul 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962857
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.