510(k) K080811 ยท NDY Test, Cystatin C
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 20, 2008 |
| Received | Mar 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080811
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.