510(k) K821964 ยท JHT Chromatographic Separation, Cpk Isoenzymes
125I QUICK-MB TEST KIT FOR QUANTITATION
| Applicant | Intl. Immunoassay Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 22, 1982 |
| Received | Jul 1, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821964
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.