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DDB — Ceruloplasmin, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DDB
Device Class
Class II
Regulation Number
866.5210
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161508beckman coulter irelandCeruloplasminJanuary 9, 2017
K122965binding site groupHUMAN CAERULOPLASMIN KITJune 3, 2013
K053074dade behringN ANTISERA TO HUMAN CERULOPLASMINMarch 16, 2006
K964762beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTApril 25, 1997
K913668binding siteCAERULOPLASMIN IMMUNOLOGICAL NL TEST KITDecember 20, 1991
K895377kallestad diag, a div. of erbamontQM300 CERULOPLASMIN ANTIBODY PACKSeptember 21, 1989
K860138sigma diagnosticsNO. 615 DETERMINATION OF CERULOPLASMIN IN SERUMMarch 28, 1986
K850682kent laboratories72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLNovember 25, 1985
K852247behring diagnosticsLASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)July 10, 1985
K851283cooper biomedicalRADIAL IMMUNODIFFUSION PLATES-CERULOPLASMINMay 23, 1985
K823107kallestad laboratoriesQUANTIMETRIC 2 CERULOPLASMIN ASSAYNovember 16, 1982
K812486dakoIMMUNOGL. FRCT. OF RABBIT ANTISER.-CERULSeptember 23, 1981
K801661j.t. baker chemicalJ.T. BAKER CERULOPLASMIN NEPHELOMETRICSeptember 16, 1980
K791339beckman instrumentsHUMAN CERULOPLASMINAugust 16, 1979
K790712kent laboratoriesANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULIAugust 16, 1979
K790714kent laboratoriesANTISERUM TO HUMAN CERULOPLASMINAugust 16, 1979
K781024icl scientificCERUOPLASMIN SERUM ANTI-HUMANAugust 14, 1978
K772255kallestad laboratoriesCERULOPLASMIN NEPHEL. ASSAYJanuary 5, 1978
K771795hyland therapeutic div., travenol laboratoriesLAS-R CERULOPLASMIN TESTNovember 14, 1977