510(k) K070853

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 by Dade Behring, Inc. — Product Code DIC

K070853 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022". The FDA issued a decision of Substantially Equivalent on June 13, 2007. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.