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510(k) Data Aggregation

    K Number
    K011979
    Device Name
    ALLERSHARP ALLERGY SKIN TESTER
    Manufacturer
    HMB MEDICAL CONCEPTS, LTD.
    Date Cleared
    2001-09-14

    (81 days)

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

    HMB MEDICAL CONCEPTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device system is used for prick application of allergen extracts in the performance of skin testing.
    Device Description
    Not Found
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