510(k) K041596 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
ARCHITECT STAT CK-MB IMMUNOASSAY
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Jul 21, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041596
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.