FDA 510(k) Application Details - K113768

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K113768
Device Name	Glucose Dehydrogenase, Glucose
Applicant	TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP NEW TAIPEI CITY 248 TW Other 510(k) Applications for this Company
Contact	MEIRU LI Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	LFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2011
Decision Date	04/12/2012
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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