510(k) K030687 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Jun 27, 2003 |
| Received | Mar 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030687
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.