FDA 510(k) Application Details - K043197

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K043197
Device Name	Glucose Oxidase, Glucose
Applicant	LIFESCAN, INC. 1000 GIBRALTAR DR. MILPITAS, CA 95035-6312 US Other 510(k) Applications for this Company
Contact	MARY ELLEN HOLDEN 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	11/18/2004
Decision Date	05/20/2005
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