510(k) K030012 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 17, 2003 |
| Received | Jan 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030012
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.