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

    LANCER L-INA ANTI-IGM

    K Number: K791402 · Decision Oct 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    191
    Review Days
    79

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    Basic Information

    Device Name
    LANCER L-INA ANTI-IGM
    K Number
    K791402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Sherwood Medical Co.
    Date Received
    July 30, 1979
    Decision Date
    October 17, 1979
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

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