FDA 510(k) Application Details - K070763

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K070763
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 BOONTON TOWNSHIP, NJ 07005 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	DHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2007
Decision Date	05/22/2007
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