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

    GSP NEONATAL BIOTINIDASE KIT

    K Number: K131284 · Decision Nov 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    22
    Review Days
    192

    Basic Information

    Device Name
    GSP NEONATAL BIOTINIDASE KIT
    K Number
    K131284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1118
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WALLAC OY
    Date Received
    May 6, 2013
    Decision Date
    November 14, 2013
    Product Code
    NAK
    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
    NAK System, Test, Biotinidase

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