510(k) K201441

Elecsys Troponin T Gen 5 by Roche Diagnostics — Product Code MMI

K201441 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Troponin T Gen 5". The FDA issued a decision of Substantially Equivalent on September 21, 2021. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics has at least 10 other 510(k) clearances on record.