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

    CERULOPLASMIN NEPHEL. ASSAY

    K Number: K772255 · Decision Jan 5, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    92
    Review Days
    27

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    Basic Information

    Device Name
    CERULOPLASMIN NEPHEL. ASSAY
    K Number
    K772255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    December 9, 1977
    Decision Date
    January 5, 1978
    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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