510(k) K991707

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 by Beckman — Product Code DHX

K991707 is an FDA 510(k) premarket notification submitted by Beckman for the device "MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206". The FDA issued a decision of Substantially Equivalent on June 1, 1999. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Beckman has at least 5 other 510(k) clearances on record.