510(k) K060935

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT by Beckman Coulter, Inc. — Product Code CGX

K060935 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS CREATININE (CREA) REAGENT". The FDA issued a decision of Substantially Equivalent on April 28, 2006. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.