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

    HDL/CHOLESTEROL TEST SYSTEM

    K Number: K861244 · Decision Sep 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    180

    Basic Information

    Device Name
    HDL/CHOLESTEROL TEST SYSTEM
    K Number
    K861244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CHROMETRICS LABORATORIES, INC.
    Date Received
    April 2, 1986
    Decision Date
    September 29, 1986
    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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