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510(k) Data Aggregation

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

    DORMER LABORATORIES, INC.

    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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