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

    ACA HIGH DENSITY LIPOPROTEIN CHOLES.

    K Number: K792509 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    253
    Review Days
    37

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    Basic Information

    Device Name
    ACA HIGH DENSITY LIPOPROTEIN CHOLES.
    K Number
    K792509
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    December 5, 1979
    Decision Date
    January 11, 1980
    Product Code
    CHH
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

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