FDA 510(k) Application Details - K102338

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K102338
Device Name	Devices, Breath Trapping, Alcohol
Applicant	Akers Biosciences, Inc. 201 GROVE RD. THOROFARE, NJ 08086 US Other 510(k) Applications for this Company
Contact	BARBARA A BAGBY Other 510(k) Applications for this Contact
Regulation Number	862.3050   More FDA Info for this Regulation Number
Classification Product Code	DJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2010
Decision Date	01/12/2011
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