FDA 510(k) Application Details - K083188

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K083188
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	PHADIA US INC. 4169 COMMERCIAL AVE. PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	MARTIN R MANN Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2008
Decision Date	03/13/2009
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