BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇪 Ireland

    APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT

    K Number: K950383 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    116
    Review Days
    227

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    Basic Information

    Device Name
    APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
    K Number
    K950383
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    January 31, 1995
    Decision Date
    September 15, 1995
    Product Code
    JHN
    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
    JHN Turbidimetric Method, Lipoproteins

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