BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500— 510(k) K053332

Name: FDA 510(k) clearance K053332
Creator: U.S. Food and Drug Administration
Published: 2006-01-20

Substantially Equivalent

Sentech Korea Corp.

FDA 510(k) clearance K053332 for BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500, Substantially Equivalent on 2006-01-20. Applicant: Sentech Korea Corp.. Device class: 1.

Clearance details

Applicant: Sentech Korea Corp.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2005-12-01
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palisades Park, NJ, US

Download summary PDF View on FDA.gov ↗

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