510(k) K935463 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE-MB (CK-MB) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jan 11, 1994 |
| Received | Nov 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935463
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.