510(k) K994439 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 14, 2000 |
| Received | Dec 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994439
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.