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

    HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)

    K Number: K915272 · Decision Mar 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    52
    Review Days
    113

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    Basic Information

    Device Name
    HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
    K Number
    K915272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemagen Diagnostics, Inc.
    Date Received
    November 25, 1991
    Decision Date
    March 17, 1992
    Product Code
    LJM
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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