510(k) K234005

Access CK-MB by Beckman Coulter, Inc. — Product Code JHX

K234005 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access CK-MB". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.