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FDA 510(k)

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST

K-Number: K102225 · 2011-04-06

ApplicantAlcopro, Inc.
Decision Date2011-04-06
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Alcopro, Inc.. It received FDA 510(k) clearance on 2011-04-06 under 510(k) number K102225. 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 ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST?

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST is a medical device that received FDA 510(k) clearance on 2011-04-06. The listed applicant is Alcopro, Inc.. The 510(k) number is K102225.

When did ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST receive FDA 510(k) clearance?

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST received FDA 510(k) clearance on 2011-04-06, under 510(k) number K102225.

Who is the listed applicant for ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST?

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

What is the FDA product code for ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST?

The FDA product code for ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST is DJZ.

Related Clinical Trials

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Related Devices (Code: DJZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLCK123470PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITEPas Systems International, Inc.K110614PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEMSeju Engineering Co., Ltd.K102338BREATHSCN PROAkers Biosciences, Inc.K100879CONTRALCOContralcoK093143MISSION BREATH ALCOHOL DETECTORACON Laboratories, Inc.

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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