FDA 510(k) Application Details - K113007

Device Classification Name	Calculator/Data Processing Module, For Clinical Use   More FDA Info for this Device
510(K) Number	K113007
Device Name	Calculator/Data Processing Module, For Clinical Use
Applicant	BIONIME CORPORATION 27001 LA PAZ RD. 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	862.2100   More FDA Info for this Regulation Number
Classification Product Code	JQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2011
Decision Date	02/27/2012
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