510(k) K013538

ETHANOL by Abbott Laboratories — Product Code DML

K013538 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ETHANOL". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Abbott Laboratories has at least 10 other 510(k) clearances on record.