510(k) K252393

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack by Ortho-Clinical Diagnostics, Inc. — Product Code MMI

K252393 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS Immunodiagnostic Products hs Troponin I Reagent Pack". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.