510(k) K024210

IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR by Beckman Coulter, Inc. — Product Code DGC

K024210 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on February 24, 2003. The device falls under product code DGC (Ige, 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.