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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMARTPRACTICE

    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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