FDA 510(k) Application Details - K041891

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K041891
Device Name	System, Test, Rheumatoid Factor
Applicant	THE BINDING SITE WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BLVD. 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	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2004
Decision Date	11/05/2004
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