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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
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FINN CHAMBERS AQUA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a letter from the FDA regarding a change in product code for the "Finn Chambers Aqua" device. It is a reclassification notice and does not contain information about acceptance criteria or performance studies for the device itself.

    Therefore, I cannot provide the requested information based on the provided text. The document is administrative in nature and does not describe device performance or testing.

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