510(k) K013062 ยท MMI Immunoassay Method, Troponin Subunit
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
| Applicant | Biocheck, Inc., Northridge CA, US |
| Decision | Substantially Equivalent, Jan 8, 2002 |
| Received | Sep 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013062
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.