510(k) K063351 ยท NDY Test, Cystatin C
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 22, 2007 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063351
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.