510(k) K172783

Access hs Tnl by Beckman Coulter, Inc. — Product Code MMI

K172783 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access hs Tnl". The FDA issued a decision of Substantially Equivalent on June 12, 2018. 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.