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

    WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

    K Number: DEN990008 · Decision Feb 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
    K Number
    DEN990008
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.1118
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Wallac, Inc.
    Date Received
    December 20, 1999
    Decision Date
    February 15, 2000
    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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    Other Clearances by Wallac, Inc.

    K Number Device Name
    K982307 WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000