DML · Class II · 21 CFR 862.3040

FDA Product Code DML: Nad-nadh, Specific Reagent For Alcohol Enzyme Method

Leading manufacturers include Syva Co., Abbott Laboratories and Em Diagnostic Systems, Inc..

13
Total
13
Cleared
65d
Avg days
1984
Since

FDA 510(k) Cleared Nad-nadh, Specific Reagent For Alcohol Enzyme Method Devices (Product Code DML)

13 devices
1–13 of 13
Cleared Dec 14, 2001
ETHANOL
K013538
Abbott Laboratories
Toxicology · 51d
Cleared Feb 01, 2000
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980
Syva Co.
Toxicology · 69d
Cleared Sep 19, 1996
ON.SITE ALCOHOL
K963197
Ansys, Inc.
Toxicology · 35d
Cleared Sep 27, 1995
AXSYM REA ETHANOL
K953765
Abbott Laboratories
Toxicology · 47d
Cleared Aug 24, 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
K952839
Boehringer Mannheim Corp.
Toxicology · 64d
Cleared Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
K914777
Sigma Diagnostics, Inc.
Toxicology · 65d
Cleared Jan 11, 1988
RAICHEM(TM) ALCOHOL REAGENT
K874382
Reagents Applications, Inc.
Toxicology · 77d
Cleared Jul 07, 1987
KINETIC 610 ETHANOL
K872180
American Monitor Corp.
Toxicology · 29d
Cleared Sep 29, 1986
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
K863419
Em Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Apr 13, 1984
PARAMAX ALCOHOL REAGENT
K840769
American Dade
Chemistry · 65d
Cleared Mar 23, 1984
EMIT ST SERUM ETHYL ALCOHOL ASSAY
K840400
Syva Co.
Toxicology · 53d
Cleared Mar 19, 1984
EMIT ST URINE ETHYL ALCOHOL ASSAY
K840171
Syva Co.
Toxicology · 62d

About Product Code DML - Regulatory Context