510(k) K990774

ABBOTT ARCHITECT CEA by Abbott Laboratories — Product Code DHX

K990774 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT CEA". The FDA issued a decision of Substantially Equivalent on May 11, 1999. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Abbott Laboratories has at least 10 other 510(k) clearances on record.