510(k) K012208

ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 by Beckman Coulter, Inc. — Product Code DDC

K012208 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895". The FDA issued a decision of Substantially Equivalent on September 7, 2001. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.