FDA 510(k) Applications for Medical Device Product Code "DDB"
(Ceruloplasmin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K161508 BECKMAN COULTER IRELAND INC. Ceruloplasmin 01/09/2017
K964762 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT 04/25/1997
K053074 DADE BEHRING, INC. N ANTISERA TO HUMAN CERULOPLASMIN 03/16/2006
K122965 THE BINDING SITE GROUP, LTD. HUMAN CAERULOPLASMIN KIT 06/03/2013


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