510(k) K854501 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CK(OPTIMIZED) REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 4, 1985 |
| Received | Nov 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854501
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.