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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    U-TROL LIQUID URINE DIPSTICK CONTROL

    K Number: K934257 · Decision Nov 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    U-TROL LIQUID URINE DIPSTICK CONTROL
    K Number
    K934257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Meditrol
    Date Received
    August 31, 1993
    Decision Date
    November 26, 1993
    Product Code
    JJW
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

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