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

    UNITEST-POTASSIUM

    K Number: K812677 · Decision Oct 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    21
    Review Days
    10

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    Basic Information

    Device Name
    UNITEST-POTASSIUM
    K Number
    K812677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biodynamics Corp.
    Date Received
    September 22, 1981
    Decision Date
    October 2, 1981
    Product Code
    CEJ
    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
    CEJ Tetraphenyl Borate, Colorimetry, Potassium

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