FDA 510(k) Application Details - K102316

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K102316
Device Name	Glucose Oxidase, Glucose
Applicant	BROADMASTER BIOTECH CORPORATION 7F, NO. 168-2, LIANCHENG ZHONGHE CITY 23553 TW Other 510(k) Applications for this Company
Contact	ROGER LAI 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	08/16/2010
Decision Date	10/07/2011
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