510(k) K053090

DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR by Beckman Coulter, Inc. — Product Code JFM

K053090 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 16, 2005. The device falls under product code JFM (Enzymatic Method, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.