510(k) K024193 ยท MMI Immunoassay Method, Troponin Subunit
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Feb 21, 2003 |
| Received | Dec 20, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024193
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.