510(k) K874545 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
IMACK-MB TEST PROCEDURE (MODIFICATION)
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Dec 18, 1987 |
| Received | Nov 3, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874545
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.