FDA 510(k) Application Details - K030775

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K030775
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	IMMUNO CONCEPTS, N.A., LTD 2280 SPRINGLAKE RD. SUITE 106 DALLAS, TX 75234 US Other 510(k) Applications for this Company
Contact	ERIC S HOY Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2003
Decision Date	05/12/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review