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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    LIASYS 450

    K Number: K113131 · Decision Mar 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    LIASYS 450
    K Number
    K113131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ams
    Date Received
    October 24, 2011
    Decision Date
    March 8, 2012
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

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