FDA 510(k) Application Details - K050662

Device Classification Name	Autoantibodies, Nuclear Body Protein, Sp100   More FDA Info for this Device
510(K) Number	K050662
Device Name	Autoantibodies, Nuclear Body Protein, Sp100
Applicant	INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. SAN DIEGO, CA 92131 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	NUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2005
Decision Date	06/13/2005
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