FDA 510(k) Application Details - K081338

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K081338
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant	Roche Diagnostics 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	STEPHANIE GREEMAN 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	05/13/2008
Decision Date	09/11/2008
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