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510(k) Data Aggregation

    K Number
    K123184
    Device Name
    FINN CHAMBERS AQUA
    Manufacturer
    SMART PRACTICE
    Date Cleared
    2012-12-19

    (70 days)

    Product Code
    KXF, LDH
    Regulation Number
    880.6025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
    Device Description
    Not Found
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    K Number
    K103409
    Device Name
    ALLERGEAZE R CLEAR
    Manufacturer
    SMARTPRACTICE
    Date Cleared
    2011-03-15

    (113 days)

    Product Code
    KXF, LDH
    Regulation Number
    880.6025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.
    Device Description
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    K Number
    K063160
    Device Name
    ALLERGEAZE PATCH TEST CHAMBERS
    Manufacturer
    SMART PRACTICE
    Date Cleared
    2006-12-22

    (66 days)

    Product Code
    KXF, LDH
    Regulation Number
    880.6025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
    Device Description
    Not Found
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    K Number
    K013820
    Device Name
    FINN CHAMBER (R)
    Manufacturer
    EPITEST LTD. OY
    Date Cleared
    2002-01-30

    (75 days)

    Product Code
    KXF, LDH
    Regulation Number
    880.6025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-thecounter use.
    Device Description
    Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing.
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    K Number
    K992553
    Device Name
    IQ CHAMBERS
    Manufacturer
    DORMER LABORATORIES, INC.
    Date Cleared
    2000-04-12

    (257 days)

    Product Code
    KXF, LDH
    Regulation Number
    880.6025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.
    Device Description
    The product is a plastic tray with shallow indentations or chambers for use as a place allergens or allergen mixes in contact with the surface of the skin during allergen patch tests.
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    K Number
    K970357
    Device Name
    EPISCREEN
    Manufacturer
    EPITOPE, INC.
    Date Cleared
    1997-03-10

    (39 days)

    Product Code
    PJD
    Regulation Number
    862.1675
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory. EpiScreen is intended for use in the collection, preservation, and transport of oral fluid specimens.
    Device Description
    The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosa. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.
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