FDA 510(k) Application Details - K991801

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K991801
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
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	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MSV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1999
Decision Date	05/05/2000
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