510(k) K093626 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
INNOVANCE D-DIMER, MODEL OPBP09
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Nov 29, 2010 |
| Received | Nov 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093626
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.