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

    SGOT REAGENT SET

    K Number: K820466 · Decision Mar 11, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    26
    Review Days
    17

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    Basic Information

    Device Name
    SGOT REAGENT SET
    K Number
    K820466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    February 22, 1982
    Decision Date
    March 11, 1982
    Product Code
    CIQ
    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
    CIQ Diazo, Ast/Sgot

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