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510(k) Data Aggregation

    K Number
    K960648
    Device Name
    PHEM-CHEK
    Manufacturer
    FEMTEK, INC.
    Date Cleared
    1996-05-13

    (89 days)

    Product Code
    LNW
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pHEM-CHEK is intended for checking the pH level of a woman's vagina.
    Device Description
    The pHEM-CHEK is comprised of a flat probe on which a strip of phenaphthazine pH paper is mounted. One end of the probe will be textured for better gripping and a strip of phenaphthazine pH paper will be mounted on the flat surface of the opposing end. A color chart, provided by the manufacturer of the pH paper, will be enclosed in each box of probes.
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