BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    URINE TRANSPORT KIT

    K Number: K843359 · Decision Sep 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    31

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    Basic Information

    Device Name
    URINE TRANSPORT KIT
    K Number
    K843359
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Applied Polytechnology, Inc.
    Date Received
    August 27, 1984
    Decision Date
    September 27, 1984
    Product Code
    JTW
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTW System, Transport, Aerobic

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