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

    IGA MININEPH ANTISERUM

    K Number: K981786 · Decision Nov 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    11
    Applicant Total
    115
    Review Days
    553

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    Basic Information

    Device Name
    IGA MININEPH ANTISERUM
    K Number
    K981786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    May 20, 1998
    Decision Date
    November 24, 1999
    Product Code
    CFQ
    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
    CFQ Radioimmunoassay, Immunoglobulins (G, A, M)

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