FDA 510(k) Application Details - K041478

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K041478
Device Name	Glucose Oxidase, Glucose
Applicant	BECTON DICKINSON 1 BECTON DR. FRANKLIN LAKES, NJ 07417-1880 US Other 510(k) Applications for this Company
Contact	JOHN SCHALAGO 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	06/03/2004
Decision Date	10/28/2004
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