FDA 510(k) Application Details - K130500

Device Classification Name	Electrophoretic, Protein Fractionation   More FDA Info for this Device
510(K) Number	K130500
Device Name	Electrophoretic, Protein Fractionation
Applicant	SEBIA 1705 CORPORATE DRIVE SUITE 400 DULUTH, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	862.1630   More FDA Info for this Regulation Number
Classification Product Code	CEF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2013
Decision Date	07/26/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review