FDA 510(k) Application Details - K020823

Device Classification Name	Igg (Gamma Chain Specific), Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K020823
Device Name	Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Applicant	SANQUIN BLOOD SUPPLY FOUNDATION 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DFZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2002
Decision Date	05/14/2002
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