510(k) K141143 ยท NDY Test, Cystatin C
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 17, 2014 |
| Received | May 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141143
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.