510(k) K152227 ยท JFT Fluorometric, Cortisol
Elecsys Cortisol II, Cortisol II CalSet
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 27, 2016 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152227
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.