BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

    K Number: K082811 · Decision Sep 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    352

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    Basic Information

    Device Name
    URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
    K Number
    K082811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Urit Medical Electronic Co., Ltd.
    Date Received
    September 24, 2008
    Decision Date
    September 11, 2009
    Product Code
    JIO
    Advisory Committee
    Hematology
    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
    JIO Blood, Occult, Colorimetric, In Urine

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JIO), ordered by most recent decision date.

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    MISSION U500 URINE ANALYZER

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    URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

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    Other Clearances by Urit Medical Electronic Co., Ltd.

    K Number Device Name
    K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips