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

    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

    K Number: K050823 · Decision Jul 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    51
    Review Days
    117

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    Basic Information

    Device Name
    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
    K Number
    K050823
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teco Diagnostics
    Date Received
    March 31, 2005
    Decision Date
    July 26, 2005
    Product Code
    LBR
    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
    LBR Ldl & Vldl Precipitation, Hdl

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