BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS

    K Number: K130321 · Decision Apr 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    60

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    Basic Information

    Device Name
    LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
    K Number
    K130321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1045
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diasorin
    Date Received
    February 8, 2013
    Decision Date
    April 9, 2013
    Product Code
    CJM
    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
    CJM Radioimmunoassay, Aldosterone

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