510(k) K890609 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 16, 1989 |
| Received | Feb 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890609
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.