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

    IQ HDL CHOLESTEROL

    K Number: K881891 · Decision Jun 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    79
    Applicant Total
    632
    Review Days
    36

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    Basic Information

    Device Name
    IQ HDL CHOLESTEROL
    K Number
    K881891
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    May 5, 1988
    Decision Date
    June 10, 1988
    Product Code
    LBS
    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
    LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

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