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DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Class II

FDA Device Classification

Classification Details

Product Code
DIC
Device Class
Class II
Regulation Number
862.3040
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250609sober ipSober Self-TestSeptember 15, 2025
K181553immunalysis corporationImmunalysis Ethyl Alcohol Enzyme AssayOctober 31, 2018
K121247chematicsALCO-SCREENMarch 22, 2013
K121256chematicsALCO-SCREEN 02September 12, 2012
K111005medicaETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALNovember 15, 2011
K111206teco diagnosticsTECO DIAGNOSTICS SALIVA ALCOHOL TESTOctober 4, 2011
K092273randox laboratoriesRANDOX ETHANOL ASSAYNovember 1, 2010
K093879acon laboratoriesMISSION SALIVA ALCOHOL TEST STRIPAugust 6, 2010
K071811dade behringETOH FLEX REAGENT CARTRIDGE (DF22)August 24, 2007
K070853dade behringDIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022June 13, 2007
K061792dade behringDIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLJuly 18, 2006
K032461lin-zhi internationalETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221October 3, 2003
K023184bayer diagnosticsETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMNovember 18, 2002
K010960syva co., dade behringEMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229April 26, 2001
K001286diagnostic chemicalsETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10June 20, 2000
K993920diagnostic chemicalsETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17January 18, 2000
K974002diagnostic chemicalsETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12April 1, 1998
K972725pointe scientific, incALCOHOL REAGENT SETSeptember 25, 1997
K972011behring diagnosticsOPUS ETHANOLJuly 22, 1997
K955633diagnostic chemicalsENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03May 24, 1996