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510(k) Data Aggregation

    K Number
    DEN990008
    Device Name
    WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
    Manufacturer
    WALLAC, INC.
    Date Cleared
    2000-02-15

    (57 days)

    Product Code
    NAK
    Regulation Number
    862.1118
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982307
    Device Name
    WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
    Manufacturer
    WALLAC, INC.
    Date Cleared
    1999-02-02

    (216 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease.
    Device Description
    Not Found
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