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

    VS-SENSE TEST

    K Number: K091287 · Decision Aug 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    122

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    Basic Information

    Device Name
    VS-SENSE TEST
    K Number
    K091287
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Common Sense , Ltd.
    Date Received
    May 1, 2009
    Decision Date
    August 31, 2009
    Product Code
    CEN
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)

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