Panels › Clinical Toxicology › Product code DIC · Class 2
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Regulation 862.3040
0510(k)s in 12 months (33 all time)
1recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in DIC
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Chemicals , Ltd. | 4 | 0 |
| Abbott Laboratories | 3 | 0 |
| Dade Behring, Inc. | 3 | 0 |
| Carolina Liquid Chemistries | 0 | 2 |
| Chematics, Inc. | 2 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 2 | 0 |
| Lin-Zhi International, Inc. | 1 | 1 |
| Abbott Laboratories HPD/ADD/GPRD | 0 | 1 |
| ACON Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2025 | K250609 | Sober Self-Test Sober Ip, LLC | DIC |
| Oct 31, 2018 | K181553 | Immunalysis Ethyl Alcohol Enzyme Assay Immunalysis Corporation | DIC |
| Mar 22, 2013 | K121247 | ALCO-SCREEN Chematics, Inc. | DIC |
| Sep 12, 2012 | K121256 | ALCO-SCREEN 02 Chematics, Inc. | DIC |
| Nov 15, 2011 | K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL Medica Corp. | DIC |
| Oct 4, 2011 | K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST Teco Diagnostics | DIC |
| Nov 1, 2010 | K092273 | RANDOX ETHANOL ASSAY Randox Laboratories, Ltd., GB | DIC |
| Aug 6, 2010 | K093879 | MISSION SALIVA ALCOHOL TEST STRIP ACON Laboratories, Inc. | DIC |
| Aug 24, 2007 | K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) Dade Behring, Inc. | DIC |
| Jun 13, 2007 | K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 Dade Behring, Inc. | DIC |
| Jul 18, 2006 | K061792 | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI Dade Behring, Inc. | DIC |
| Oct 3, 2003 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc. | DIC |
| Nov 18, 2002 | K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | DIC |
| Apr 26, 2001 | K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 Syva Co., Dade Behring, Inc. | DIC |
| Jun 20, 2000 | K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 Diagnostic Chemicals , Ltd., CA | DIC |
| Jan 18, 2000 | K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 Diagnostic Chemicals , Ltd., CA | DIC |
| Apr 1, 1998 | K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 Diagnostic Chemicals , Ltd., CA | DIC |
| Sep 25, 1997 | K972725 | ALCOHOL REAGENT SET Pointe Scientific, Inc., | DIC |
| Jul 22, 1997 | K972011 | OPUS ETHANOL Behring Diagnostics, Inc. | DIC |
| May 24, 1996 | K955633 | ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 Diagnostic Chemicals , Ltd., CA | DIC |
| Apr 26, 1994 | K934275 | PARAMAX ALCOHOL REAGENT Baxter Diagnostics, Inc. | DIC |
| Jul 19, 1993 | K931516 | STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY Solarcare Technologies Corp,Inc. | DIC |
| Aug 12, 1991 | K913125 | ROCHE REAGENT FOR ETHANOL Roche Diagnostic Systems, Inc. | DIC |
| Oct 12, 1990 | K904302 | DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD E.I. Dupont DE Nemours & Co., Inc. | DIC |
| Oct 12, 1990 | K903235 | STATLAB A-350 SALIVA ALCOHOL TEST Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | DIC |
| Aug 9, 1990 | K903153 | EMIT ETHYL ALCOHOL ASSAY Syva Co. | DIC |
| Apr 5, 1990 | K894001 | SALIVA ALCOHOL TEST Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | DIC |
| Aug 25, 1989 | K890743 | AD X(TM) ETHANOL Abbott Laboratories | DIC |
| Jan 24, 1989 | K881344 | ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS E.I. Dupont DE Nemours & Co., Inc. | DIC |
| Jun 11, 1987 | K871645 | TDXR REA(TM) ETHANOL Abbott Laboratories | DIC |
| Nov 5, 1985 | K854130 | DEMAND ETHYL ALCOHOL Cooper Biomedical, Inc. | DIC |
| Apr 13, 1984 | K840826 | TDX ETHANOL Abbott Laboratories | DIC |
| Jun 8, 1977 | K770975 | ANTI-CONVULSANT DRUG CONTROL Lederle Laboratories | DIC |
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