FDA 510(k) Applications for Medical Device Product Code "DML"
(Nad-Nadh, Specific Reagent For Alcohol Enzyme Method)

FDA 510(k) Number Applicant Device Name Decision Date
K953765 ABBOTT LABORATORIES AXSYM REA ETHANOL 09/27/1995
K013538 ABBOTT LABORATORIES ETHANOL 12/14/2001
K840769 AMERICAN DADE PARAMAX ALCOHOL REAGENT 04/13/1984
K872180 AMERICAN MONITOR CORP. KINETIC 610 ETHANOL 07/07/1987
K963197 ANSYS, INC. ON.SITE ALCOHOL 09/19/1996
K952839 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY 08/24/1995
K863419 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) ALCOHOL TESTPACKS, #67691/95 09/29/1986
K874382 REAGENTS APPLICATIONS, INC. RAICHEM(TM) ALCOHOL REAGENT 01/11/1988
K914777 SIGMA DIAGNOSTICS, INC. SIGMA PROCEDURE NO. 333-UV 12/27/1991
K840400 SYVA CO. EMIT ST SERUM ETHYL ALCOHOL ASSAY 03/23/1984
K840171 SYVA CO. EMIT ST URINE ETHYL ALCOHOL ASSAY 03/19/1984
K993980 SYVA CO. SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL 02/01/2000
K923337 TOXI-LAB, INC. ON*SITE ALCOHOL 01/12/1993


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