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

    HDL-CHOLESTEROL PRECIPITATING REAGENT

    K Number: K883543 · Decision Dec 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    107
    Review Days
    119

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    Basic Information

    Device Name
    HDL-CHOLESTEROL PRECIPITATING REAGENT
    K Number
    K883543
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    August 19, 1988
    Decision Date
    December 16, 1988
    Product Code
    CHH
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

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