510kDecisions.com

FDA 510(k) Applications for Medical Device Product Code "DIC"
(Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)

FDA 510(k) Number Applicant Device Name Decision Date
K890743 ABBOTT LABORATORIES AD X(TM) ETHANOL 8/25/1989
K840826 ABBOTT LABORATORIES TDX ETHANOL 4/13/1984
K871645 ABBOTT LABORATORIES TDXR REA(TM) ETHANOL 6/11/1987
K093879 ACON LABORATORIES, INC. MISSION SALIVA ALCOHOL TEST STRIP 08/06/2010
K934275 BAXTER DIAGNOSTICS, INC. PARAMAX ALCOHOL REAGENT 4/26/1994
K023184 BAYER DIAGNOSTICS CORP. ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM 11/18/2002
K972011 BEHRING DIAGNOSTICS, INC. OPUS ETHANOL 07/22/1997
K121247 CHEMATICS, INC. ALCO-SCREEN 03/22/2013
K121256 CHEMATICS, INC. ALCO-SCREEN 02 09/12/2012
K854130 COOPER BIOMEDICAL, INC. DEMAND ETHYL ALCOHOL 11/5/1985
K061792 DADE BEHRING, INC. DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI 07/18/2006
K070853 DADE BEHRING, INC. DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 06/13/2007
K071811 DADE BEHRING, INC. ETOH FLEX REAGENT CARTRIDGE (DF22) 08/24/2007
K955633 DIAGNOSTIC CHEMICALS LTD. ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 05/24/1996
K993920 DIAGNOSTIC CHEMICALS LTD. ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 01/18/2000
K001286 DIAGNOSTIC CHEMICALS LTD. ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 06/20/2000
K974002 DIAGNOSTIC CHEMICALS LTD. ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 04/01/1998
K881344 E.I. DUPONT DE NEMOURS & CO., INC. ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS 1/24/1989
K904302 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD 10/12/1990
K894001 ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY SALIVA ALCOHOL TEST 4/5/1990
K903235 ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY STATLAB A-350 SALIVA ALCOHOL TEST 10/12/1990
K770975 LEDERLE LABORATORIES ANTI-CONVULSANT DRUG CONTROL 6/8/1977
K032461 LIN-ZHI INTERNATIONAL, INC. ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 10/03/2003
K111005 MEDICA CORP. ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL 11/15/2011
K972725 POINTE SCIENTIFIC, INC. ALCOHOL REAGENT SET 09/25/1997
K092273 RANDOX LABORATORIES, LTD. RANDOX ETHANOL ASSAY 11/01/2010
K913125 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR ETHANOL 8/12/1991
K931516 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY 7/19/1993
K903153 SYVA CO. EMIT ETHYL ALCOHOL ASSAY 8/9/1990
K010960 SYVA CO., DADE BEHRING, INC. EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 04/26/2001
K111206 TECO DIAGNOSTICS TECO DIAGNOSTICS SALIVA ALCOHOL TEST 10/04/2011


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