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

    BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST

    K Number: K925183 · Decision Feb 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    14
    Review Days
    132

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    Basic Information

    Device Name
    BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
    K Number
    K925183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton Biomedix
    Date Received
    October 14, 1992
    Decision Date
    February 23, 1993
    Product Code
    KTN
    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
    KTN System, Test, Infectious Mononucleosis

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