510(k) K981985

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 by Beckman Coulter, Inc. — Product Code DHX

K981985 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209". The FDA issued a decision of Substantially Equivalent on September 24, 1998. 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.