FDA 510(k) Application Details - K052133

Device Classification Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)   More FDA Info for this Device
510(K) Number	K052133
Device Name	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant	EURODIAGNOSTICA 1306 BAILES LANE, SUITE F FREDERICK, MD 21701 US Other 510(k) Applications for this Company
Contact	WILLIAM L BOTELER JR. 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	08/05/2005
Decision Date	12/12/2005
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