FDA 510(k) Application Details - K123087

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K123087
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	TYSON BIORESEARCH, INC. 5 F., # 22, KE E. ROAD III SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY 350 TW Other 510(k) Applications for this Company
Contact	WEN-HAI TSAI 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	10/01/2012
Decision Date	06/18/2013
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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