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
K093879 ACON LABORATORIES, INC. MISSION SALIVA ALCOHOL TEST STRIP 08/06/2010
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
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
K181553 Immunalysis Corporation Immunalysis Ethyl Alcohol Enzyme Assay 10/31/2018
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
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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