FDA 510(k) Application Details - K022083

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K022083
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 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	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2002
Decision Date	07/16/2002
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