FDA 510(k) Application Details - K173511

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K173511
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Sheena Song 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	11/13/2017
Decision Date	07/12/2018
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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