FDA 510(k) Application Details - K013283

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K013283
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2001
Decision Date	11/14/2001
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