510(k) K071811

ETOH FLEX REAGENT CARTRIDGE (DF22) by Dade Behring, Inc. — Product Code DIC

K071811 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "ETOH FLEX REAGENT CARTRIDGE (DF22)". The FDA issued a decision of Substantially Equivalent on August 24, 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.