510(k) K112416 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CPK REAGENT
| Applicant | Vital Diagnostics (Manufacturing) Ptyltd, Noble Park, AU |
| Decision | Substantially Equivalent, Nov 9, 2011 |
| Received | Aug 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112416
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.