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

    HDL CHOLESTEROL REAGENT (PTA/MGCL2)

    K Number: K890023 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    164
    Review Days
    44

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    Basic Information

    Device Name
    HDL CHOLESTEROL REAGENT (PTA/MGCL2)
    K Number
    K890023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    January 4, 1989
    Decision Date
    February 17, 1989
    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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