510(k) K002642 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
MINIQUANT D-DIMER, MODEL 1447
| Applicant | Biopool Intl., Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Feb 5, 2001 |
| Received | Aug 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002642
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.