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

    ANTISERA TO RABBIT IMMUNOGLOBULIN

    K Number: K790720 · Decision Aug 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    40
    Review Days
    126

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    Basic Information

    Device Name
    ANTISERA TO RABBIT IMMUNOGLOBULIN
    K Number
    K790720
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    April 12, 1979
    Decision Date
    August 16, 1979
    Product Code
    DFZ
    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
    DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control

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