FDA 510(k) Application Details - K140210

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K140210
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	BIONIME CORPORATION 29222 RANCHO VIEJO ROAD SUITE 218 SAN JUN CAPISTRANO, CA 92675 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	01/28/2014
Decision Date	08/22/2014
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