FDA 510(k) Application Details - K992041

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K992041
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	IMMUNO CONCEPTS, INC. 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	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/1999
Decision Date	07/23/1999
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