DMT · Class II · 21 CFR 862.3040

FDA Product Code DMT: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Leading manufacturers include Syva Co., Beckman Coulter, Inc. and Diagnostic Chemicals, Ltd. (Usa).

8
Total
8
Cleared
68d
Avg days
1980
Since

FDA 510(k) Cleared Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Devices (Product Code DMT)

8 devices
1–8 of 8
Cleared Apr 10, 2000
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410
Beckman Coulter, Inc.
Toxicology · 62d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506
Beckman Instruments, Inc.
Toxicology · 39d
Cleared Mar 21, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
K934273
Eastman Kodak Company
Toxicology · 202d
Cleared Jan 21, 1993
ETHYL ALCOHOL ASSAY
K923783
Diagnostic Reagents, Inc.
Toxicology · 177d
Cleared Jan 09, 1987
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894
Em Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Sep 14, 1984
ETHYL ALCOHOL ASSAY KIT
K843378
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 17d
Cleared Mar 06, 1981
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL ASSAY
K802621
Syva Co.
Toxicology · 11d

About Product Code DMT - Regulatory Context