FDA 510(k) Application Details - K161508

Device Classification Name	Ceruloplasmin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K161508
Device Name	Ceruloplasmin, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER IRELAND INC. LISMEEHAN O' CALLAGHAN'S, MILLS CO. CLARE IE Other 510(k) Applications for this Company
Contact	MARGUERITA SWEENEY Other 510(k) Applications for this Contact
Regulation Number	866.5210   More FDA Info for this Regulation Number
Classification Product Code	DDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2016
Decision Date	01/09/2017
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