FDA 510(k) Application Details - K083868

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K083868
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND DD2 1XA GB Other 510(k) Applications for this Company
Contact	Claire Dora 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	12/29/2008
Decision Date	09/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review