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510(k) Data Aggregation

    K Number
    K162917
    Device Name
    Allerhope Allergy Skin Tester
    Manufacturer
    PROCARE INDUSTRIAL CO., LIMITED
    Date Cleared
    2017-08-17

    (303 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROCARE INDUSTRIAL CO., LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
    Device Description
    Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.
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