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FDA 510(k) Application Details - K062971
Device Classification Name
Devices, Breath Trapping, Alcohol
More FDA Info for this Device
510(K) Number
K062971
Device Name
Devices, Breath Trapping, Alcohol
Applicant
Akers Biosciences, Inc.
201 GROVE RD.
THOROFARE, NJ 08086 US
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Contact
BARBARA A BAGBY
Other 510(k) Applications for this Contact
Regulation Number
862.3050
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Classification Product Code
DJZ
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More FDA Info for this Product Code
Date Received
09/29/2006
Decision Date
12/18/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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