510(k) K974776 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
MDA D-DIMER
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Apr 16, 1998 |
| Received | Dec 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974776
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.