FDA 510(k) Application Details - K121576

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K121576
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant	Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	SUSAN BROCCHI 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	05/30/2012
Decision Date	04/04/2013
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