FDA Product Code
FDA Product Code DIC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3040
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250609 | Sober Self-Test | Sober Ip, LLC | 2025-09-15 | Traditional | PDF ↗ |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | Immunalysis Corporation | 2018-10-31 | Traditional | PDF ↗ |
| K121247 | ALCO-SCREEN | Chematics, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K121256 | ALCO-SCREEN 02 | Chematics, Inc. | 2012-09-12 | Traditional | PDF ↗ |
| K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | Medica Corp. | 2011-11-15 | Traditional | PDF ↗ |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Teco Diagnostics | 2011-10-04 | Traditional | PDF ↗ |
| K092273 | RANDOX ETHANOL ASSAY | Randox Laboratories, Ltd. | 2010-11-01 | Traditional | PDF ↗ |
| K093879 | MISSION SALIVA ALCOHOL TEST STRIP | ACON Laboratories, Inc. | 2010-08-06 | Traditional | PDF ↗ |
| K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) | Dade Behring, Inc. | 2007-08-24 | Traditional | PDF ↗ |
| K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | Dade Behring, Inc. | 2007-06-13 | Traditional | PDF ↗ |
| K061792 | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI | Dade Behring, Inc. | 2006-07-18 | Special | PDF ↗ |
| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | Lin-Zhi International, Inc. | 2003-10-03 | Traditional | PDF ↗ |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2002-11-18 | Traditional | PDF ↗ |
| K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | Syva Co., Dade Behring, Inc. | 2001-04-26 | Special | PDF ↗ |
| K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | Diagnostic Chemicals , Ltd. | 2000-06-20 | Traditional | PDF ↗ |
| K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | Diagnostic Chemicals , Ltd. | 2000-01-18 | Traditional | PDF ↗ |
| K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | Diagnostic Chemicals , Ltd. | 1998-04-01 | Traditional | PDF ↗ |
| K972725 | ALCOHOL REAGENT SET | Pointe Scientific, Inc., | 1997-09-25 | Traditional | PDF ↗ |
| K972011 | OPUS ETHANOL | Behring Diagnostics, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K955633 | ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 | Diagnostic Chemicals , Ltd. | 1996-05-24 | Traditional | PDF ↗ |
| K934275 | PARAMAX ALCOHOL REAGENT | Baxter Diagnostics, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K931516 | STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY | Solarcare Technologies Corp,Inc. | 1993-07-19 | Traditional | PDF ↗ |
| K913125 | ROCHE REAGENT FOR ETHANOL | Roche Diagnostic Systems, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K903235 | STATLAB A-350 SALIVA ALCOHOL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990-10-12 | Traditional | PDF ↗ |
| K904302 | DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K903153 | EMIT ETHYL ALCOHOL ASSAY | Syva Co. | 1990-08-09 | Traditional | PDF ↗ |
| K894001 | SALIVA ALCOHOL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990-04-05 | Traditional | PDF ↗ |
| K890743 | AD X(TM) ETHANOL | Abbott Laboratories | 1989-08-25 | Traditional | PDF ↗ |
| K881344 | ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K871645 | TDXR REA(TM) ETHANOL | Abbott Laboratories | 1987-06-11 | Traditional | PDF ↗ |
| K854130 | DEMAND ETHYL ALCOHOL | Cooper Biomedical, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K840826 | TDX ETHANOL | Abbott Laboratories | 1984-04-13 | Traditional | PDF ↗ |
| K770975 | ANTI-CONVULSANT DRUG CONTROL | Lederle Laboratories | 1977-06-08 | Traditional | PDF ↗ |
Product code DIC · Class II · Clinical Toxicology. Data: openFDA.