ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST— 510(k) K102225

Name: FDA 510(k) clearance K102225
Creator: U.S. Food and Drug Administration
Published: 2011-04-06

Substantially Equivalent

Alcopro, Inc.

FDA 510(k) clearance K102225 for ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST, Substantially Equivalent on 2011-04-06. Applicant: Alcopro, Inc.. Device class: 1.

Clearance details

Applicant: Alcopro, Inc.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2010-08-09
Decision date: 2011-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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