510(k) K032419 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
QUANTEX D-DIMER
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Oct 24, 2003 |
| Received | Aug 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032419
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.