510(k) K850212 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
ISOENZYME TEST CK-MB
| Applicant | Sclavo, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Feb 7, 1985 |
| Received | Jan 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850212
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.