510(k) K093458

SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 by Beckman Coulter, Inc. — Product Code JFY

K093458 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.