510(k) K002948 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Sep 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002948
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.