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

    URINE CHEMISTRY ANALYZER UR-50

    K Number: K063390 · Decision Mar 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    8
    Review Days
    112

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    Basic Information

    Device Name
    URINE CHEMISTRY ANALYZER UR-50
    K Number
    K063390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostic, Inc.
    Date Received
    November 9, 2006
    Decision Date
    March 1, 2007
    Product Code
    JIL
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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    Other Clearances by Ind Diagnostic, Inc.

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    K060810 ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
    K052694 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    K052662 ONE STEP FSH MENOPAUSAL TEST
    K050741 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
    K023638 CASSETTE/URINE HCG