FDA 510(k) Application Details - K163087

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K163087
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	iXensor Company Ltd. 9F, No. 473, Sec. 2, Tiding Blvd., Neihu Dist. Taipei City 114 TW Other 510(k) Applications for this Company
Contact	JAMIE WU 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	11/03/2016
Decision Date	11/02/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review