510(k) K092740

ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 by Abbott Laboratories — Product Code CGN

K092740 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Abbott Laboratories has at least 10 other 510(k) clearances on record.