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

    SGPT REAGENT SET

    K Number: K844283 · Decision Nov 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    22

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    Basic Information

    Device Name
    SGPT REAGENT SET
    K Number
    K844283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Livonia Diagnostics, Inc.
    Date Received
    November 5, 1984
    Decision Date
    November 27, 1984
    Product Code
    CKD
    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
    CKD Hydrazone Colorimetry, Alt/Sgpt

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