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510(k) Data Aggregation

    K Number
    K000299
    Device Name
    DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
    Manufacturer
    Date Cleared
    2000-04-28

    (88 days)

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

    BIOMEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique. DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur. Clinical settings appropriate for use of this system would include professional medical environments such as physician clinics and hospitals. The target population appropriate for use of this system would include both pediatric and adult patients. As is common in all allergy skin test procedures, this device is appropriate for use on the forearms or back in accordance with commonly accepted practices of physicians trained in allergy skin testing.
    Device Description
    DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
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