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

    AIMSTICK URINE REAGENT STRIPS

    K Number: K051727 · Decision Oct 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    120

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    Basic Information

    Device Name
    AIMSTICK URINE REAGENT STRIPS
    K Number
    K051727
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Germaine Laboratories, Inc.
    Date Received
    June 28, 2005
    Decision Date
    October 26, 2005
    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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