Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032461 FDA 510(k)
- FDA Product Code
- DIC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3040 FDA 510(k)
- Regulation Number
- 862.3040 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, used for the quantitative determination of ethyl alcohol in clinical specimens. It is classified as a Class II medical device under regulation number 862.3040 and product code DIC.
The assay is supplied as a reagent system for in vitro diagnostic use, with catalog numbers 0220 and 0221. It received FDA 510(k) clearance (K032461) on October 3, 2003, as substantially equivalent to a legally marketed device, and is intended for use in clinical laboratory settings for toxicology testing.
Frequently asked questions
What is the purpose of the Ethyl Alcohol Enzymatic Assay?
The Ethyl Alcohol Enzymatic Assay is an in vitro diagnostic reagent system used for the quantitative determination of ethyl alcohol in clinical specimens, specifically designed for toxicology testing in clinical laboratory settings.
How is the Ethyl Alcohol Enzymatic Assay supplied?
The assay is supplied as a reagent system with catalog numbers 0220 and 0221, intended for in vitro diagnostic use in clinical laboratories for the quantitative determination of ethyl alcohol in clinical specimens.
What is the regulatory classification of this device?
The device is classified as a Class II medical device under regulation number 862.3040 and product code DIC. It received FDA 510(k) clearance (K032461) on October 3, 2003, as substantially equivalent to a legally marketed device.
What is the intended use setting for this assay?
The Ethyl Alcohol Enzymatic Assay is intended for use in clinical laboratory settings for toxicology testing, where it serves as an Alcohol Dehydrogenase reagent system for the quantitative determination of ethyl alcohol in clinical specimens.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ethyl group - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032461 | Class II | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K032461 24 fields · synced Oct 6, 2026