510(k) K030012

CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 by Beckman Coulter, Inc. — Product Code JHX

K030012 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372". The FDA issued a decision of Substantially Equivalent on January 17, 2003. 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.