510(k) K030328 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, Sep 2, 2003 |
| Received | Jan 31, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030328
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.