510(k) K051925 ยท MMI Immunoassay Method, Troponin Subunit
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
| Applicant | Access Bio Incorporate, Monmouth Jct. NJ, US |
| Decision | Substantially Equivalent, Nov 29, 2005 |
| Received | Jul 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051925
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.