FDA 510(k) Application Details - K120236

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K120236
Device Name	Transferrin, Antigen, Antiserum, Control
Applicant	THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON BIRMINGHAM, WEST MIDLANDS B15 1QT GB Other 510(k) Applications for this Company
Contact	JILL CONSTANTINE Other 510(k) Applications for this Contact
Regulation Number	866.5880   More FDA Info for this Regulation Number
Classification Product Code	DDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2012
Decision Date	02/13/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review