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

    FITKIT I CHECKUP KIT

    K Number: K830340 · Decision Aug 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    195

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    Basic Information

    Device Name
    FITKIT I CHECKUP KIT
    K Number
    K830340
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1785
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boditestor
    Date Received
    February 2, 1983
    Decision Date
    August 16, 1983
    Product Code
    CDM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

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