FDA 510(k) Application Details - K150412

Device Classification Name	Complement C9, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K150412
Device Name	Complement C9, Antigen, Antiserum, Control
Applicant	The Binding Site Group Ltd 8 Calthorpe Road, Edgbaston B15 1QT GB Other 510(k) Applications for this Company
Contact	Marianne Sender Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	DAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2015
Decision Date	08/28/2015
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