FDA 510(k) Application Details - K142336

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K142336
Device Name	Glucose Oxidase, Glucose
Applicant	ARKRAY FACTORY INC. 1480 KOJI KONAN-CHO KOKA-SHI 520-3306 JP Other 510(k) Applications for this Company
Contact	Kazuya Yorimitsu 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	08/21/2014
Decision Date	09/17/2014
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
Expedited Review