510(k) K872063 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 19, 1987 |
| Received | May 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872063
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.