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

    ANTISERUM, HUMAN, IGA

    K Number: K790703 · Decision Apr 12, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    53
    Applicant Total
    40
    Review Days
    —

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    Basic Information

    Device Name
    ANTISERUM, HUMAN, IGA
    K Number
    K790703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Kent Laboratories, Inc.
    Date Received
    April 12, 1979
    Decision Date
    April 12, 1979
    Product Code
    CZP
    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
    CZP Iga, Antigen, Antiserum, Control

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