510(k) K031270

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS by Beckman Coulter, Inc. — Product Code DHX

K031270 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.