510(k) K852392 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 22, 1985 |
| Received | Jun 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852392
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.