510(k) K840769

PARAMAX ALCOHOL REAGENT by American Dade — Product Code DML

K840769 is an FDA 510(k) premarket notification submitted by American Dade for the device "PARAMAX ALCOHOL REAGENT". The FDA issued a decision of Substantially Equivalent on April 13, 1984. 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. American Dade has at least 10 other 510(k) clearances on record.