Atlas FDA

DIC

33 FDA 510(k) clearances · Product code

77 daysmedian time to decision
300 days90th percentile
33clearances measured

FDA profile

Official device name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3040
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Sober Self-Test (K250609)Sober Ip, LLC2025-09-15
Immunalysis Ethyl Alcohol Enzyme Assay (K181553)Immunalysis Corporation2018-10-31
ALCO-SCREEN (K121247)Chematics, Inc.2013-03-22
ALCO-SCREEN 02 (K121256)Chematics, Inc.2012-09-12
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (K111005)Medica Corp.2011-11-15
TECO DIAGNOSTICS SALIVA ALCOHOL TEST (K111206)Teco Diagnostics2011-10-04
RANDOX ETHANOL ASSAY (K092273)Randox Laboratories, Ltd.2010-11-01
MISSION SALIVA ALCOHOL TEST STRIP (K093879)ACON Laboratories, Inc.2010-08-06
ETOH FLEX REAGENT CARTRIDGE (DF22) (K071811)Dade Behring, Inc.2007-08-24
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (K070853)Dade Behring, Inc.2007-06-13
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI (K061792)Dade Behring, Inc.2006-07-18
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 (K032461)Lin-Zhi International, Inc.2003-10-03
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K023184)Bayer Diagnostics Corp.2002-11-18
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 (K010960)Syva Co., Dade Behring, Inc.2001-04-26
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 (K001286)Diagnostic Chemicals , Ltd.2000-06-20
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 (K993920)Diagnostic Chemicals , Ltd.2000-01-18
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 (K974002)Diagnostic Chemicals , Ltd.1998-04-01
ALCOHOL REAGENT SET (K972725)Pointe Scientific, Inc.,1997-09-25
OPUS ETHANOL (K972011)Behring Diagnostics, Inc.1997-07-22
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 (K955633)Diagnostic Chemicals , Ltd.1996-05-24
PARAMAX ALCOHOL REAGENT (K934275)Baxter Diagnostics, Inc.1994-04-26
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY (K931516)Solarcare Technologies Corp,Inc.1993-07-19
ROCHE REAGENT FOR ETHANOL (K913125)Roche Diagnostic Systems, Inc.1991-08-12
STATLAB A-350 SALIVA ALCOHOL TEST (K903235)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1990-10-12
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD (K904302)E.I. Dupont DE Nemours & Co., Inc.1990-10-12
EMIT ETHYL ALCOHOL ASSAY (K903153)Syva Co.1990-08-09
SALIVA ALCOHOL TEST (K894001)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1990-04-05
AD X(TM) ETHANOL (K890743)Abbott Laboratories1989-08-25
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS (K881344)E.I. Dupont DE Nemours & Co., Inc.1989-01-24
TDXR REA(TM) ETHANOL (K871645)Abbott Laboratories1987-06-11
DEMAND ETHYL ALCOHOL (K854130)Cooper Biomedical, Inc.1985-11-05
TDX ETHANOL (K840826)Abbott Laboratories1984-04-13
ANTI-CONVULSANT DRUG CONTROL (K770975)Lederle Laboratories1977-06-08

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Every clearance here is in the API, with alerts when new ones post.