BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS— 510(k) K062971

Name: FDA 510(k) clearance K062971
Creator: U.S. Food and Drug Administration
Published: 2006-12-18

Substantially Equivalent

Akers Biosciences, Inc.

FDA 510(k) clearance K062971 for BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS, Substantially Equivalent on 2006-12-18. Applicant: Akers Biosciences, Inc.. Device class: 1.

Clearance details

Applicant: Akers Biosciences, Inc.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2006-09-29
Decision date: 2006-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thorofare, NJ, US

Download summary PDF View on FDA.gov ↗

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