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

    IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM

    K Number: K812487 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    54
    Review Days
    23

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    Basic Information

    Device Name
    IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
    K Number
    K812487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Dako Corp.
    Date Received
    August 31, 1981
    Decision Date
    September 23, 1981
    Product Code
    DAO
    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
    DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

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    Other Clearances by Dako Corp.

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