FDA 510(k) Application Details - K143118

Device Classification Name	Albumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K143118
Device Name	Albumin, Antigen, Antiserum, Control
Applicant	THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, BIRMINGHAM B15 1QT GB Other 510(k) Applications for this Company
Contact	Marianne Sender Other 510(k) Applications for this Contact
Regulation Number	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2014
Decision Date	05/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review