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FDA 510(k)

MISSION BREATH ALCOHOL DETECTOR

K-Number: K093143 · 2010-01-28

ApplicantACON Laboratories, Inc.
Decision Date2010-01-28
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MISSION BREATH ALCOHOL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K093143. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISSION BREATH ALCOHOL DETECTOR?

MISSION BREATH ALCOHOL DETECTOR is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K093143.

When did MISSION BREATH ALCOHOL DETECTOR receive FDA 510(k) clearance?

MISSION BREATH ALCOHOL DETECTOR received FDA 510(k) clearance on 2010-01-28, under 510(k) number K093143.

Who is the listed applicant for MISSION BREATH ALCOHOL DETECTOR?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISSION BREATH ALCOHOL DETECTOR?

The FDA product code for MISSION BREATH ALCOHOL DETECTOR is DJZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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