Etoh Flex Reagent Cartridge (DF22)
FDA 510(k) K071811 · Dade Behring, Inc.
510(k) numberK071811
Submission
- Device name
- Etoh Flex Reagent Cartridge (DF22)
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- July 3, 2007
- Decision date
- August 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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 |
| K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022DIC · Traditional | Dade Behring, Inc. | 06/13/2007SE |
| K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…DIC · Special | Dade Behring, Inc. | 07/18/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Etoh Flex Reagent Cartridge (DF22) cleared by the FDA?
Etoh Flex Reagent Cartridge (DF22) (K071811) received a 510(k) decision of Substantially Equivalent on August 24, 2007, 52 days after the submission was received.
What is the product code of K071811?
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.