510(k) K994439

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 by Beckman Coulter, Inc. — Product Code JHX

K994439 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306". The FDA issued a decision of Substantially Equivalent on January 14, 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.