510(k) K060130

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT by Beckman Coulter, Inc. — Product Code CZP

K060130 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT". The FDA issued a decision of Substantially Equivalent on February 13, 2006. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.