FDA 510(k) Application Details - K061842

Device Classification Name	Autoantibodies, Nuclear Pore Glycoprotein Gp210   More FDA Info for this Device
510(K) Number	K061842
Device Name	Autoantibodies, Nuclear Pore Glycoprotein Gp210
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	GARY L NORMAN Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	NRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2006
Decision Date	10/18/2006
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