510(k) K000196

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 by Beckman Coulter, Inc. — Product Code DDR

K000196 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316". The FDA issued a decision of Substantially Equivalent on February 18, 2000. 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.