510(k) K000492 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
MDA D-DIMER
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jun 7, 2000 |
| Received | Feb 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000492
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.