510(k) K013062

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT by Biocheck, Inc. — Product Code MMI

K013062 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on January 8, 2002. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Biocheck, Inc. has at least 10 other 510(k) clearances on record.