510(k) K983895

IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT by Beckman Coulter, Inc. — Product Code JZG

K983895 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.