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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K062971
Device Name BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
Applicant
Akers Biosciences, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Applicant Contact BARBARA A BAGBY
Correspondent
Akers Biosciences, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Correspondent Contact BARBARA A BAGBY
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received09/29/2006
Decision Date 12/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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