FDA 510(k) Application Details - K113610

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K113610
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST BENICIA, CA 94510 US Other 510(k) Applications for this Company
Contact	Juang Wang 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	12/06/2011
Decision Date	07/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review