FDA 510(k) Application Details - K162282

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K162282
Device Name	Glucose Oxidase, Glucose
Applicant	Polymer Technology Systems, Inc. d/b/a PTS Diagnostics 7736 Zionsville Road 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	08/15/2016
Decision Date	12/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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