FDA 510(k) Application Details - K123256

Device Classification Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K123256
Device Name	Alpha-1-Antitrypsin, 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	866.5130   More FDA Info for this Regulation Number
Classification Product Code	DEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2012
Decision Date	07/03/2013
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