510(k) K021229

MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 by Beckman Coulter, Inc. — Product Code DDR

K021229 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244". The FDA issued a decision of Substantially Equivalent on June 28, 2002. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.