510(k) K080662 ยท NDY Test, Cystatin C
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
| Applicant | Genzyme Corporation, Framingham MA, US |
| Decision | Substantially Equivalent, May 15, 2008 |
| Received | Mar 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080662
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.