FDA 510(k) Application Details - K023009

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K023009
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD SANTA MONICA, CA 90404 US Other 510(k) Applications for this Company
Contact	JAY H GELLER Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2002
Decision Date	01/21/2003
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