510(k) K013076

SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR by Beckman Coulter, Inc. — Product Code LEH

K013076 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 12, 2001. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.