510(k) K093137 ยท NDY Test, Cystatin C
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
| Applicant | Kamiya Biomedical Co., Tukwila WA, US |
| Decision | Substantially Equivalent, Sep 28, 2010 |
| Received | Oct 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093137
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.