510(k) K091916 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, Oct 29, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091916
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.