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
K791339 BECKMAN INSTRUMENTS, INC. HUMAN CERULOPLASMIN 08/16/1979
K964762 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT 04/25/1997
K852247 BEHRING DIAGNOSTICS, INC. LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) 07/10/1985
K851283 COOPER BIOMEDICAL, INC. RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN 05/23/1985
K053074 DADE BEHRING, INC. N ANTISERA TO HUMAN CERULOPLASMIN 03/16/2006
K812486 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL 09/23/1981
K771795 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R CERULOPLASMIN TEST 11/14/1977
K781024 ICL SCIENTIFIC CERUOPLASMIN SERUM ANTI-HUMAN 08/14/1978
K801661 J.T. BAKER CHEMICAL CO. J.T. BAKER CERULOPLASMIN NEPHELOMETRIC 09/16/1980
K895377 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CERULOPLASMIN ANTIBODY PACK 09/21/1989
K772255 KALLESTAD LABORATORIES, INC. CERULOPLASMIN NEPHEL. ASSAY 01/05/1978
K823107 KALLESTAD LABORATORIES, INC. QUANTIMETRIC 2 CERULOPLASMIN ASSAY 11/16/1982
K850682 KENT LABORATORIES, INC. 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL 11/25/1985
K790714 KENT LABORATORIES, INC. ANTISERUM TO HUMAN CERULOPLASMIN 08/16/1979
K790712 KENT LABORATORIES, INC. ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI 08/16/1979
K860138 SIGMA DIAGNOSTICS, INC. NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM 03/28/1986
K122965 THE BINDING SITE GROUP, LTD. HUMAN CAERULOPLASMIN KIT 06/03/2013
K913668 THE BINDING SITE, LTD. CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT 12/20/1991


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