FDA 510(k) Application Details - K963275

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K963275
Device Name	Extractable Antinuclear Antibody, Antigen And Control
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	LLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/1996
Decision Date	09/13/1996
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