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FDA 510(k)

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS

K-Number: K062971 · 2006-12-18

ApplicantAkers Biosciences, Inc.
Decision Date2006-12-18
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Akers Biosciences, Inc.. It received FDA 510(k) clearance on 2006-12-18 under 510(k) number K062971. 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 BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS?

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-12-18. The listed applicant is Akers Biosciences, Inc.. The 510(k) number is K062971.

When did BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS receive FDA 510(k) clearance?

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS received FDA 510(k) clearance on 2006-12-18, under 510(k) number K062971.

Who is the listed applicant for BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS?

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

What is the FDA product code for BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS?

The FDA product code for BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS is DJZ.

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Other records listing Akers Biosciences, Inc. as applicant

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.

K102338BREATHSCN PROK060761BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORSK052697HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANELK050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

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.K102225ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTAlcopro, Inc.K102338BREATHSCN PROAkers Biosciences, Inc.K100879CONTRALCOContralco

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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