FDA 510(k) Application Details - K955431

Device Classification Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K955431
Device Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, 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	866.5660   More FDA Info for this Regulation Number
Classification Product Code	DBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/1995
Decision Date	04/23/1996
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