510(k) K964934 ยท MIF Prothrombin Fragment 1.2
THROMBONOSTIKA F1.2
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964934
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.