510(k) K033491 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 1, 2004 |
| Received | Nov 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033491
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.