510(k) K832139 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | Jun 27, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832139
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.