FDA 510(k) Application Details - K124021

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K124021
Device Name	Glucose Oxidase, Glucose
Applicant	ARKRAY FACTORY INC. 5198 WEST 76TH ST EDINA, MN 55439 US Other 510(k) Applications for this Company
Contact	LONNA M DENDOOVEN 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	12/27/2012
Decision Date	06/30/2014
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