Alco-Screen 02
FDA 510(k) K121256 · Chematics, Inc.
510(k) numberK121256
Submission
- Device name
- Alco-Screen 02
- Applicant
- Chematics, Inc.
North Webster, IN, US - Received
- April 25, 2012
- Decision date
- September 12, 2012
- 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
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 |
| 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 |
| 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 |
|---|---|---|
| K121247 | Alco-ScreenDIC · Traditional | 03/22/2013SE |
Questions and answers
When was Alco-Screen 02 cleared by the FDA?
Alco-Screen 02 (K121256) received a 510(k) decision of Substantially Equivalent on September 12, 2012, 140 days after the submission was received.
What is the product code of K121256?
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.