FDA 510(k) Application Details - K111728

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K111728
Device Name	Glucose Oxidase, Glucose
Applicant	EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK HSINCHU CITY, HSINCHU 30077 TW Other 510(k) Applications for this Company
Contact	YC LEI Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2011
Decision Date	09/16/2011
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
Expedited Review