FDA 510(k) Application Details - K082965

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K082965
Device Name	Glucose Oxidase, Glucose
Applicant	ALLIANCE INTERNATIONAL CO., LTD. NO.58, FU-CHIUN ST. HSIN CHU CITY 30067 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	10/03/2008
Decision Date	12/07/2009
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