FDA 510(k) Application Details - K091657

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K091657
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant	EURO-DIAGNOSTICA AB LUNDAVAGEN 151 MALMO SE-212 24 SE Other 510(k) Applications for this Company
Contact	ANNIKA ANDERSSON 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	06/09/2009
Decision Date	11/19/2009
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