FDA 510(k) Application Details - K122110

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K122110
Device Name	Glucose Oxidase, Glucose
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM ROAD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	QIYI XIE 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	07/17/2012
Decision Date	11/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review