FDA 510(k) Application Details - K120448

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K120448
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	LISA LIU 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	02/14/2012
Decision Date	04/06/2012
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
Expedited Review