FDA 510(k) Application Details - K113636

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K113636
Device Name	Glucose Oxidase, Glucose
Applicant	PHILOSYS CO. LTD. 304 PARK AVENUE SOUTH SUITE 218 NEW YORK, NY 10010 US Other 510(k) Applications for this Company
Contact	LINDA CHAN 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	12/09/2011
Decision Date	03/08/2013
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