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

    72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

    K Number: K850682 · Decision Nov 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    40
    Review Days
    277

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    Basic Information

    Device Name
    72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
    K Number
    K850682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    February 21, 1985
    Decision Date
    November 25, 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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