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

    URINE SCREENING DEVICE

    K Number: K972676 · Decision Feb 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    1
    Review Days
    222

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    Basic Information

    Device Name
    URINE SCREENING DEVICE
    K Number
    K972676
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Combact Diagnostic Systems , Ltd.
    Date Received
    July 16, 1997
    Decision Date
    February 23, 1998
    Product Code
    JXA
    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
    JXA Kit, Screening, Urine

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