FDA 510(k) Application Details - K113547

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K113547
Device Name	Glucose Oxidase, Glucose
Applicant	APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078 TW Other 510(k) Applications for this Company
Contact	HSUE-MEI LEE 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	12/01/2011
Decision Date	03/28/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review