FDA 510(k) Application Details - K122965

Device Classification Name	Ceruloplasmin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K122965
Device Name	Ceruloplasmin, Antigen, Antiserum, Control
Applicant	THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD WEST MIDLANDS EDGBASTON B15 1QT GB Other 510(k) Applications for this Company
Contact	JILL CONSTANTINE Other 510(k) Applications for this Contact
Regulation Number	866.5210   More FDA Info for this Regulation Number
Classification Product Code	DDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2012
Decision Date	06/03/2013
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