510(k) K161817 ยท NDY Test, Cystatin C
Tina-quant Cystatin C Gen.2
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 27, 2016 |
| Received | Jul 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161817
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.