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

    VITROS CHEMISTRY PRODUCTS DHDL SLIDES

    K Number: K120609 · Decision Sep 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    79
    Applicant Total
    106
    Review Days
    191

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    Basic Information

    Device Name
    VITROS CHEMISTRY PRODUCTS DHDL SLIDES
    K Number
    K120609
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho-Clinical Diagnostics, Inc.
    Date Received
    February 29, 2012
    Decision Date
    September 7, 2012
    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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