510(k) K890543 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
IMPRES-MB REAGENT A AND REAGENT B
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 13, 1989 |
| Received | Feb 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890543
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.