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

    PHOSPHOTUNGSTATE REDUCTION, URIC ACID

    K Number: K813076 · Decision Nov 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    73
    Review Days
    14

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    Basic Information

    Device Name
    PHOSPHOTUNGSTATE REDUCTION, URIC ACID
    K Number
    K813076
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    November 2, 1981
    Decision Date
    November 16, 1981
    Product Code
    CDH
    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
    CDH Acid, Uric, Phosphotungstate Reduction

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