FDA 510(k) Application Details - K013068

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K013068
Device Name	Glucose Oxidase, Glucose
Applicant	POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	MARGO ENRIGHT 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	06/28/2001
Decision Date	11/20/2001
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