Immunalysis Ethyl Alcohol Enzyme Assay— 510(k) K181553

Name: FDA 510(k) clearance K181553
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K181553 for Immunalysis Ethyl Alcohol Enzyme Assay, Substantially Equivalent on 2018-10-31. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2018-06-13
Decision date: 2018-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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