510(k) K901450 ยท JHT Chromatographic Separation, Cpk Isoenzymes
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, May 15, 1990 |
| Received | Mar 28, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901450
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.