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510(k) Data Aggregation

    K Number
    K050352
    Device Name
    IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
    Manufacturer
    AMERITEK RESEARCH LLC
    Date Cleared
    2005-09-01

    (202 days)

    Product Code
    JTO, JIO, JIR, JMT, LJX, LNW
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERITEK RESEARCH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis when used in conjunction with other laboratory tests such as Gram stain, microscopic examination, and clinical signs and symptoms. The FemLab Vaginitis Test Kit is for professional and laboratory use only.
    Device Description
    Not Found
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