FDA 510(k) Application Details - K120615

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K120615
Device Name	Glucose Oxidase, Glucose
Applicant	ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	EDWARD BREHM, PH.D. 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	02/29/2012
Decision Date	05/15/2013
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