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

    VITROS CHEMISTRY PRODUCTS TRIG SLIDES

    K Number: K130332 · Decision May 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    150
    Applicant Total
    106
    Review Days
    109

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    Basic Information

    Device Name
    VITROS CHEMISTRY PRODUCTS TRIG SLIDES
    K Number
    K130332
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho-Clinical Diagnostics, Inc.
    Date Received
    February 11, 2013
    Decision Date
    May 31, 2013
    Product Code
    CDT
    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
    CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

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