510(k) K921763 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 9, 1992 |
| Received | Apr 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921763
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.