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 American Dade.

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 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