FDA 510(k) Application Details - K092450

Device Classification Name	Igd, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K092450
Device Name	Igd, Antigen, Antiserum, Control
Applicant	THE BINDING SITE 12100 WILSHIRE BLVD SUITE 500 LOS ANGELES, CA 90025 US Other 510(k) Applications for this Company
Contact	JAY GELLER Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2009
Decision Date	12/28/2009
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