Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221
FDA 510(k) K032461 · Lin-Zhi International, Inc.
510(k) numberK032461
Submission
- Device name
- Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221
- Applicant
- Lin-Zhi International, Inc.
Synnyvale, CA, US - Received
- August 11, 2003
- Decision date
- October 3, 2003
- 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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Questions and answers
When was Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 cleared by the FDA?
Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 (K032461) received a 510(k) decision of Substantially Equivalent on October 3, 2003, 53 days after the submission was received.
What is the product code of K032461?
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.