510(k) K881351 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 1, 1988 |
| Received | Mar 30, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881351
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.