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

    MONOSTAR SYSTEM: IM LATEX TEST

    K Number: K861452 · Decision May 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    2
    Review Days
    25

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    Basic Information

    Device Name
    MONOSTAR SYSTEM: IM LATEX TEST
    K Number
    K861452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    U.S. Health Resources Corp.
    Date Received
    April 18, 1986
    Decision Date
    May 13, 1986
    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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    Other Clearances by U.S. Health Resources Corp.

    K Number Device Name
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