FDA 510(k) Application Details - K053079

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K053079
Device Name	Glucose Oxidase, Glucose
Applicant	HYPOGUARD USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	BRUCE A MACFARLANE 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	11/02/2005
Decision Date	03/28/2006
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