510(k) K884085 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 2, 1988 |
| Received | Sep 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884085
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.