510(k) K881281 ยท GKP Instrument, Coagulation, Automated
COAG-A-MATE(R) XM
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, May 18, 1988 |
| Received | Mar 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881281
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.