IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)— 510(k) K081855

Name: FDA 510(k) clearance K081855
Creator: U.S. Food and Drug Administration
Published: 2008-12-19

Substantially Equivalent

Canada, Inc.

FDA 510(k) clearance K081855 for IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS), Substantially Equivalent on 2008-12-19. Applicant: Canada, Inc.. Device class: 1.

Clearance details

Applicant: Canada, Inc.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2008-06-30
Decision date: 2008-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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