510(k) K000410

SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS by Beckman Coulter, Inc. — Product Code DMT

K000410 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on April 10, 2000. The device falls under product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet), a Class II device regulated under 21 CFR 862.3040. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.