ALCOHAWK PRECISION— 510(k) K043188

Substantially Equivalent

Q3 Innovations, LLC

FDA 510(k) clearance K043188 for ALCOHAWK PRECISION, Substantially Equivalent on 2005-02-09. Applicant: Q3 Innovations, LLC. Device class: 1.

Clearance details

Applicant: Q3 Innovations, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2004-11-17
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.