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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
    Type
    Post-NSE
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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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
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA to Wallac, Inc. for their Neonatal Leucine Test Kit.

    The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, it does not describe the specific performance, acceptance criteria, or a study that directly demonstrates the device meets these criteria.

    Therefore, I cannot provide the requested information based on the given text.

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