FDA 510(k) Application Details - K083570

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K083570
Device Name	Glucose Oxidase, Glucose
Applicant	TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP TAIPEI COUNTY 241 TW Other 510(k) Applications for this Company
Contact	SOPHIE LIN 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	12/03/2008
Decision Date	03/11/2009
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