510(k) K252393 ยท MMI Immunoassay Method, Troponin Subunit
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 29, 2025 |
| Received | Jul 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252393
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.