FDA 510(k) Application Details - K112901

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K112901
Device Name	Glucose Dehydrogenase, Glucose
Applicant	EPS BIO TECHNOLOGY CORP. No.8, R&D Rd. III, Hsinchu Science Park, HSINCHU CITY 30077 TW Other 510(k) Applications for this Company
Contact	Cynthia Hung 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	10/03/2011
Decision Date	12/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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