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510(k) Data Aggregation

    K Number
    K032161
    Device Name
    PHEM-ALERT
    Manufacturer
    FEMTEK,LLC.
    Date Cleared
    2003-09-30

    (77 days)

    Product Code
    LNW
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    LNW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching - Burning - Unpleasant odor - Unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.
    Device Description
    The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package insert. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated for measuring vaginal pH for the purpose of differentiating normal and abnormal conditions in symptomatic women. The device is inserted into the vagina and the measurement taken.
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    K Number
    K012230
    Device Name
    PHEM-ALERT
    Manufacturer
    FEMTEK,LLC.
    Date Cleared
    2001-10-09

    (85 days)

    Product Code
    LNW
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    LNW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pHEM-ALERT® test mcasures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms: Itching, Burning, Unpleasant odor, Unusual discharge. This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have follow-up by your neartheate provider. This device is not validated for use in pregnant women.
    Device Description
    The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package inscrt. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated package miser. "The present of differentiating normal and abnormal conditions in for modeling vagina price is inserted into the vagina and the measurement taken.
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    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?
    Product Code :

    LNW

    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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