FDA 510(k) Application Details - K151639

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K151639
Device Name	Glucose Oxidase, Glucose
Applicant	SENDX MEDICAL INC 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	VIBEKE AGERLIN 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	06/18/2015
Decision Date	12/07/2015
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