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510(k) Data Aggregation

    K Number
    K993554
    Device Name
    YEASTEST
    Manufacturer
    DIAGNOSTIC MARKERS, INC.
    Date Cleared
    2000-02-10

    (113 days)

    Product Code
    JXB
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC MARKERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.
    Device Description
    Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit
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