Ethanol Assay for the Bayer Advia Integrated Module System
FDA 510(k) K023184 · Bayer Diagnostics Corp.
510(k) numberK023184
Submission
- Device name
- Ethanol Assay for the Bayer Advia Integrated Module System
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- September 24, 2002
- Decision date
- November 18, 2002
- 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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| K121256 | Alco-Screen 02DIC · Traditional | Chematics, Inc. | 09/12/2012SE |
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| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | Teco Diagnostics | 10/04/2011SE |
| K092273 | Randox Ethanol AssayDIC · Traditional | Randox Laboratories, Ltd. | 11/01/2010SE |
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| 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 |
|---|---|---|
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | 12/19/2003SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | 12/16/2003SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | 11/14/2003SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | 09/04/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | 03/18/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | 03/03/2003SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | 12/24/2002SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
| K022329 | Ca 125 II Assay for the Bayer Advia Integrated Module SystemLTK · Traditional | 11/27/2002SE |
Questions and answers
When was Ethanol Assay for the Bayer Advia Integrated Module System cleared by the FDA?
Ethanol Assay for the Bayer Advia Integrated Module System (K023184) received a 510(k) decision of Substantially Equivalent on November 18, 2002, 55 days after the submission was received.
What is the product code of K023184?
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.