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

    WAKO HDL CHOLESTEROL TEST

    K Number: K801834 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    79
    Applicant Total
    6
    Review Days
    46

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    Basic Information

    Device Name
    WAKO HDL CHOLESTEROL TEST
    K Number
    K801834
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Wako Pure Chemical Industries, Ltd.
    Date Received
    August 1, 1980
    Decision Date
    September 16, 1980
    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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    Other Clearances by Wako Pure Chemical Industries, Ltd.

    K Number Device Name
    K842221 WAKO GLUCOSE C
    K813366 AMMONIA TEST
    K801891 WAKO TRIGLYCERIDE-G TEST
    K801076 WAKO PHOSPHOLIPIDS TEST
    K791597 WAKO TRIGLYCERIDE