TDX Ethanol
FDA 510(k) K840826 · Abbott Laboratories
510(k) numberK840826
Submission
- Device name
- TDX Ethanol
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- February 24, 1984
- Decision date
- April 13, 1984
- 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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Questions and answers
When was TDX Ethanol cleared by the FDA?
TDX Ethanol (K840826) received a 510(k) decision of Substantially Equivalent on April 13, 1984, 49 days after the submission was received.
What is the product code of K840826?
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.