BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN

    K Number: K851283 · Decision May 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    19
    Review Days
    52

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    Basic Information

    Device Name
    RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN
    K Number
    K851283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cooper Biomedical, Inc.
    Date Received
    April 1, 1985
    Decision Date
    May 23, 1985
    Product Code
    DDB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DDB Ceruloplasmin, Antigen, Antiserum, Control

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    Other Clearances by Cooper Biomedical, Inc.

    K Number Device Name
    K863868 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
    K864512 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
    K863301 DEMAND TOTAL PROTEIN
    K861926 WORTHINGTON HDL PRECIPITATING REAGENT SET
    K854130 DEMAND ETHYL ALCOHOL
    K853949 DEMAND ACID PHOSPHATASE REAGENT
    K852262 ASSIST CLINICAL CHEMISTRY ANALYZER
    K851285 RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
    K851284 RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
    K851286 RADIAL IMMUNODIFFUSION PLATES C3 & C4
    Search all 19 clearances from Cooper Biomedical, Inc. →