TDXR Rea(Tm) Ethanol
FDA 510(k) K871645 · Abbott Laboratories
510(k) numberK871645
Submission
- Device name
- TDXR Rea(Tm) Ethanol
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 28, 1987
- Decision date
- June 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250609 | Sober Self-TestDIC · Traditional | Sober Ip, LLC | 09/15/2025SE |
| K181553 | Immunalysis Ethyl Alcohol Enzyme AssayDIC · Traditional | Immunalysis Corporation | 10/31/2018SE |
| K121247 | Alco-ScreenDIC · Traditional | Chematics, Inc. | 03/22/2013SE |
| K121256 | Alco-Screen 02DIC · Traditional | Chematics, Inc. | 09/12/2012SE |
| K111005 | Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional | Medica Corp. | 11/15/2011SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | Teco Diagnostics | 10/04/2011SE |
| K092273 | Randox Ethanol AssayDIC · Traditional | Randox Laboratories, Ltd. | 11/01/2010SE |
| K093879 | Mission Saliva Alcohol Test StripDIC · Traditional | ACON Laboratories, Inc. | 08/06/2010SE |
| K071811 | Etoh Flex Reagent Cartridge (DF22)DIC · Traditional | Dade Behring, Inc. | 08/24/2007SE |
| K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022DIC · Traditional | Dade Behring, Inc. | 06/13/2007SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was TDXR Rea(Tm) Ethanol cleared by the FDA?
TDXR Rea(Tm) Ethanol (K871645) received a 510(k) decision of Substantially Equivalent on June 11, 1987, 44 days after the submission was received.
What is the product code of K871645?
The FDA product code is DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.