FDA 510(k) Application Details - K133346

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K133346
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU SEOUL, KOREA 139-845 KR Other 510(k) Applications for this Company
Contact	HYE YOUNG KANG 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	10/30/2013
Decision Date	12/19/2013
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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