510(k) K973819 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
VIDAS D-DIMER (DD) ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Mar 10, 1998 |
| Received | Oct 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973819
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.