510(k) K991101 ยท GKP Instrument, Coagulation, Automated
COAG-A-MATE MAX
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jun 1, 1999 |
| Received | Apr 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991101
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.