510(k) K242870

Access hsTnI by Beckman Coulter, Inc. — Product Code MMI

K242870 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access hsTnI". The FDA issued a decision of Substantially Equivalent on June 16, 2025. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.