510(k) K000716

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER by Beckman Coulter, Inc. — Product Code JHX

K000716 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER". The FDA issued a decision of Substantially Equivalent on March 20, 2000. 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.