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

    ASIMANAGER - AT

    K Number: K111356 · Decision Nov 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    177

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    Basic Information

    Device Name
    ASIMANAGER - AT
    K Number
    K111356
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arlington Scientific, Inc.
    Date Received
    May 16, 2011
    Decision Date
    November 9, 2011
    Product Code
    JQT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

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