510(k) K142985

UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator by Beckman Coulter, Inc. — Product Code JIT

K142985 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator". The FDA issued a decision of Substantially Equivalent on February 26, 2015. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.