FDA 510(k) Application Details - K120423

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K120423
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	BIONIME CORPORATION 2700 LAPAZ ROAD SUITE 266B MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	Feng-Yu Lee Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2012
Decision Date	08/03/2012
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