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

    LIQUID CHROMATOGRAPH MODEL 850

    K Number: K780944 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    253
    Review Days
    49

    Basic Information

    Device Name
    LIQUID CHROMATOGRAPH MODEL 850
    K Number
    K780944
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. DUPONT DE NEMOURS & CO., INC.
    Date Received
    June 8, 1978
    Decision Date
    July 27, 1978
    Product Code
    KZR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZR Chromatography (Liquid, Gel), Clinical Use

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