510(k) K003158 ยท JHW U.V. Method, Cpk Isoenzymes
ROCHE DIAGNOSTICS CK-MB
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 18, 2000 |
| Received | Oct 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003158
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.