510(k) K041619 ยท MMI Immunoassay Method, Troponin Subunit
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
| Applicant | Biocheck, Inc., Northridge CA, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Jun 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041619
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.