510(k) K060774

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 by Beckman Coulter, Inc. — Product Code CGN

K060774 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208". The FDA issued a decision of Substantially Equivalent on April 21, 2006. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.