510(k) K930359 ยท JHT Chromatographic Separation, Cpk Isoenzymes
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 12, 1993 |
| Received | Jan 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930359
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.