DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Class II
FDA product code DIC covers "Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method", a Class II medical device regulated under 21 CFR 862.3040. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250609 | sober ip | Sober Self-Test | September 15, 2025 |
| K181553 | immunalysis corporation | Immunalysis Ethyl Alcohol Enzyme Assay | October 31, 2018 |
| K121247 | chematics | ALCO-SCREEN | March 22, 2013 |
| K121256 | chematics | ALCO-SCREEN 02 | September 12, 2012 |
| K111005 | medica | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | November 15, 2011 |
| K111206 | teco diagnostics | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | October 4, 2011 |
| K092273 | randox laboratories | RANDOX ETHANOL ASSAY | November 1, 2010 |
| K093879 | acon laboratories | MISSION SALIVA ALCOHOL TEST STRIP | August 6, 2010 |
| K071811 | dade behring | ETOH FLEX REAGENT CARTRIDGE (DF22) | August 24, 2007 |
| K070853 | dade behring | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | June 13, 2007 |
| K061792 | dade behring | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FL | July 18, 2006 |
| K032461 | lin-zhi international | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | October 3, 2003 |
| K023184 | bayer diagnostics | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | November 18, 2002 |
| K010960 | syva co., dade behring | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | April 26, 2001 |
| K001286 | diagnostic chemicals | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | June 20, 2000 |
| K993920 | diagnostic chemicals | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | January 18, 2000 |
| K974002 | diagnostic chemicals | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | April 1, 1998 |
| K972725 | pointe scientific, inc | ALCOHOL REAGENT SET | September 25, 1997 |
| K972011 | behring diagnostics | OPUS ETHANOL | July 22, 1997 |
| K955633 | diagnostic chemicals | ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 | May 24, 1996 |