FDA 510(k) Application Details - K082513

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K082513
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	LIFESCAN, INC. 1000 GIBRALTAR DR. MILPITAS, CA 95035-6312 US Other 510(k) Applications for this Company
Contact	Oyinkan Donaldson Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2008
Decision Date	10/22/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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