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

    CHOLESTEROL PROCEDURE, TEKPOINT TOTAL

    K Number: K770457 · Decision May 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    30
    Review Days
    56

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    Basic Information

    Device Name
    CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
    K Number
    K770457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Icn Pharmaceuticals, Inc.
    Date Received
    March 8, 1977
    Decision Date
    May 3, 1977
    Product Code
    CGO
    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
    CGO Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol

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