510(k) K033036

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 by Beckman Coulter, Inc. — Product Code MOI

K033036 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647". The FDA issued a decision of Substantially Equivalent on February 3, 2004. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.