FDA 510(k) Application Details - K081615

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K081615
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	OLYMPUS AMERICA, INC. LISHEEHAN, O'CALLAGHAN'S MILLS CO. CLARE IE Other 510(k) Applications for this Company
Contact	STEPHANIE G DONNELLY Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	DHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2008
Decision Date	03/18/2009
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