510(k) K162526 ยท JHW U.V. Method, Cpk Isoenzymes
Creatine Kinase-MB
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Sep 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162526
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.