BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ANTISERUM TO HUMAN IG G FC FRAGMENTS

    K Number: K790708 · Decision Aug 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    40
    Review Days
    132

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    Basic Information

    Device Name
    ANTISERUM TO HUMAN IG G FC FRAGMENTS
    K Number
    K790708
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5530
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    April 12, 1979
    Decision Date
    August 22, 1979
    Product Code
    DAS
    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
    DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control

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