510(k) K022757 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
SPIFE CK KIT, MODEL 3332, 3333
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 11, 2002 |
| Received | Aug 20, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022757
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.