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

    HEMAGEN ENA SCL-70 KIT (EIA METHOD)

    K Number: K946122 · Decision Feb 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    177
    Applicant Total
    52
    Review Days
    69

    Basic Information

    Device Name
    HEMAGEN ENA SCL-70 KIT (EIA METHOD)
    K Number
    K946122
    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
    December 15, 1994
    Decision Date
    February 22, 1995
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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