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

    CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES

    K Number: K882488 · Decision Aug 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    65
    Applicant Total
    9
    Review Days
    60

    Basic Information

    Device Name
    CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
    K Number
    K882488
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CANYON DIAGNOSTICS, INC.
    Date Received
    June 16, 1988
    Decision Date
    August 15, 1988
    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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