Aca Ethyl Alcohol (Alc) Analytical Test Packs
FDA 510(k) K881344 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK881344
Submission
- Device name
- Aca Ethyl Alcohol (Alc) Analytical Test Packs
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- March 30, 1988
- Decision date
- January 24, 1989
- 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
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|---|---|---|---|
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| 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 |
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Questions and answers
When was Aca Ethyl Alcohol (Alc) Analytical Test Packs cleared by the FDA?
Aca Ethyl Alcohol (Alc) Analytical Test Packs (K881344) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 300 days after the submission was received.
What is the product code of K881344?
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.