FDA 510(k) Application Details - K042579

Device Classification Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)   More FDA Info for this Device
510(K) Number	K042579
Device Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)
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	866.5785   More FDA Info for this Regulation Number
Classification Product Code	NBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2004
Decision Date	07/28/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review