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

    NeoBase 2 Non-derivatized MSMS Kit

    K Number: K173568 · Decision Sep 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    288

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    Basic Information

    Device Name
    NeoBase 2 Non-derivatized MSMS Kit
    K Number
    K173568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1055
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wallac Oy, Subsidiary of Perkinelmer, Inc.
    Date Received
    November 20, 2017
    Decision Date
    September 4, 2018
    Product Code
    NQL
    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
    NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

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