510(k) K883504 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
DURAZYME(R) CPK
| Applicant | American Monitor Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 13, 1988 |
| Received | Aug 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883504
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.