FDA 510(k) Application Details - K112810

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K112810
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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	866.5775   More FDA Info for this Regulation Number
Classification Product Code	NHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2011
Decision Date	10/26/2011
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