510(k) K080481

ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS by Beckman Coulter, Inc. — Product Code DDR

K080481 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 20, 2009. 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.