510(k) K823550 ยท JHT Chromatographic Separation, Cpk Isoenzymes
CK-ISOZYME U.V. REAGENT SET
| Applicant | Gelman Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 7, 1983 |
| Received | Nov 30, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823550
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.