DIC · Class II · 21 CFR 862.3040

FDA Product Code DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Leading manufacturers include Diagnostic Chemicals , Ltd., Abbott Laboratories and Dade Behring, Inc..

33
Total
33
Cleared
126d
Avg days
1977
Since
33 devices
25–33 of 33
Cleared Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
K903153
Syva Co.
Toxicology · 22d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743
Abbott Laboratories
Chemistry · 193d
Cleared Jan 24, 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 300d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645
Abbott Laboratories
Chemistry · 44d
Cleared Nov 05, 1985
DEMAND ETHYL ALCOHOL
K854130
Cooper Biomedical, Inc.
Chemistry · 27d
Cleared Apr 13, 1984
TDX ETHANOL
K840826
Abbott Laboratories
Chemistry · 49d