510(k) K080634

ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 by Beckman Coulter, Inc. — Product Code DDG

K080634 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495". The FDA issued a decision of Substantially Equivalent on August 11, 2008. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.