510(k) K063647 ยท NDY Test, Cystatin C
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
| Applicant | Thermo Electron OY, Vantaa, FI |
| Decision | Substantially Equivalent, Mar 12, 2007 |
| Received | Dec 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063647
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.