510(k) K911121 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
CIBA CORNING ACS CKMB IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Apr 3, 1991 |
| Received | Mar 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911121
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.