510(k) K896170 ยท JHT Chromatographic Separation, Cpk Isoenzymes
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 16, 1990 |
| Received | Oct 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896170
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.