MISSION BREATH ALCOHOL DETECTOR— 510(k) K093143

Name: FDA 510(k) clearance K093143
Creator: U.S. Food and Drug Administration
Published: 2010-01-28

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K093143 for MISSION BREATH ALCOHOL DETECTOR, Substantially Equivalent on 2010-01-28. Applicant: ACON Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2009-10-05
Decision date: 2010-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093143

K-number listed on FDA's recall record

Z-2322-2015 — Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.Class III·Terminated·Acon Laboratories, Inc.·20150617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093143.

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