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

    H-103 IGG, H-104 IGA, H-105 IGM

    K Number: K812821 · Decision Oct 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    15
    Review Days
    19

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    Basic Information

    Device Name
    H-103 IGG, H-104 IGA, H-105 IGM
    K Number
    K812821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    October 7, 1981
    Decision Date
    October 26, 1981
    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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