510(k) K020810 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 3, 2002 |
| Received | Mar 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020810
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.