FDA 510(k) Application Details - K100588

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K100588
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	THE BINDING SITE GROUP LTD 12100 WILSHIRE BL., 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	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2010
Decision Date	08/16/2010
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