510(k) K092505

BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 by Beckman Coulter, Inc. — Product Code DBF

K092505 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203". The FDA issued a decision of Substantially Equivalent on December 11, 2009. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.