FDA 510(k) Application Details - K080636

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K080636
Device Name	Glucose Oxidase, Glucose
Applicant	HUBDIC CO., LTD 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	MARIA F GRIFFIN 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	03/06/2008
Decision Date	02/13/2009
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