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

    NeoLSD MSMS kit

    K Number: K173829 · Decision Jul 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    NeoLSD MSMS kit
    K Number
    K173829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1488
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wallac Oy, A Subsidiary of Perkinelmer
    Date Received
    December 18, 2017
    Decision Date
    July 18, 2018
    Product Code
    PQW
    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
    PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

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