Product code DIC
- Device name
- Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3040
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250609 | Sober Self-Test | Sober Ip, LLC | 2025-09-15 |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | Immunalysis Corporation | 2018-10-31 |
| K121247 | ALCO-SCREEN | Chematics, Inc. | 2013-03-22 |
| K121256 | ALCO-SCREEN 02 | Chematics, Inc. | 2012-09-12 |
| K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | Medica Corp. | 2011-11-15 |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Teco Diagnostics | 2011-10-04 |
| K092273 | RANDOX ETHANOL ASSAY | Randox Laboratories, Ltd. | 2010-11-01 |
| K093879 | MISSION SALIVA ALCOHOL TEST STRIP | ACON Laboratories, Inc. | 2010-08-06 |
| K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) | Dade Behring, Inc. | 2007-08-24 |
| K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | Dade Behring, Inc. | 2007-06-13 |
| K061792 | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI | Dade Behring, Inc. | 2006-07-18 |
| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | Lin-Zhi International, Inc. | 2003-10-03 |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2002-11-18 |
| K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | Syva Co., Dade Behring, Inc. | 2001-04-26 |
| K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | Diagnostic Chemicals , Ltd. | 2000-06-20 |
| K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | Diagnostic Chemicals , Ltd. | 2000-01-18 |
| K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | Diagnostic Chemicals , Ltd. | 1998-04-01 |
| K972725 | ALCOHOL REAGENT SET | Pointe Scientific, Inc., | 1997-09-25 |
| K972011 | OPUS ETHANOL | Behring Diagnostics, Inc. | 1997-07-22 |
| K955633 | ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 | Diagnostic Chemicals , Ltd. | 1996-05-24 |
| K934275 | PARAMAX ALCOHOL REAGENT | Baxter Diagnostics, Inc. | 1994-04-26 |
| K931516 | STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY | Solarcare Technologies Corp,Inc. | 1993-07-19 |
| K913125 | ROCHE REAGENT FOR ETHANOL | Roche Diagnostic Systems, Inc. | 1991-08-12 |
| K903235 | STATLAB A-350 SALIVA ALCOHOL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990-10-12 |
| K904302 | DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-12 |
| K903153 | EMIT ETHYL ALCOHOL ASSAY | Syva Co. | 1990-08-09 |
| K894001 | SALIVA ALCOHOL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990-04-05 |
| K890743 | AD X(TM) ETHANOL | Abbott Laboratories | 1989-08-25 |
| K881344 | ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-24 |
| K871645 | TDXR REA(TM) ETHANOL | Abbott Laboratories | 1987-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654089 | Atellica CH Ethanol (EtohC) | Siemens Healthcare Diagnostics Inc. | 2025-10-15 |
| 00816862024531 | Wondfo | WONDFO USA CO., LTD. | 2024-05-23 |
| 10816862024538 | Wondfo | WONDFO USA CO., LTD. | 2024-05-23 |
| 10673486000993 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2022-09-07 |
| 06970429841901 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 06970429841802 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 06970429841703 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 06970429841628 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 06970429841444 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 06970429841536 | co-innovation | Co-Innovation Biotech Co., Ltd | 2022-01-15 |
| 10816862023012 | Wondfo | WONDFO USA CO., LTD. | 2021-08-20 |
| 10816862022992 | Wondfo | WONDFO USA CO., LTD. | 2021-08-20 |
| 00816862022995 | Wondfo | WONDFO USA CO., LTD. | 2021-08-20 |
| 00816862023015 | Wondfo | WONDFO USA CO., LTD. | 2021-08-20 |
| 06970429841611 | co-innovation | Co-Innovation Biotech Co., Ltd | 2021-03-29 |
| 00816862022339 | Wondfo | WONDFO USA CO., LTD. | 2020-02-20 |
| 06970429841284 | co-innovation | Co-Innovation Biotech Co., Ltd | 2019-03-22 |
| 00840937110355 | Immunalysis | IMMUNALYSIS CORP | 2017-09-07 |
| 00840937110362 | Immunalysis | IMMUNALYSIS CORP | 2017-09-07 |
| 00840937110379 | Immunalysis | IMMUNALYSIS CORP | 2017-09-07 |
| 00840937110386 | Immunalysis | IMMUNALYSIS CORP | 2017-09-07 |
| 00682607200054 | Mission Saliva Test Strips | Acon Laboratories, Inc. | 2016-09-26 |
| 10763924097224 | Accustrip Saliva Alcohol Test | JANT PHARMACAL CORPORATION | 2016-09-24 |
| 00816862020380 | Wondfo Saliva Alcohol Test | WONDFO USA CO., LTD. | 2016-09-20 |
| 04015630918959 | Ethanol Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 00817302021387 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021370 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021363 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021349 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00608337150308 | Q.E.D. Saliva Alcohol Test A150 | Orasure Technologies, Inc. | 2016-07-29 |