FDA 510(k) Application Details - K003959

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K003959
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. SAN DIEGO, CA 92131-1234 US Other 510(k) Applications for this Company
Contact	BRY C MYERS 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	12/21/2000
Decision Date	01/22/2001
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