510(k) K162895 ยท MMI Immunoassay Method, Troponin Subunit
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 18, 2017 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162895
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.