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

    ALLERSHARP ALLERGY SKIN TESTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device system is used for prick application of allergen extracts in the performance of skin testing.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is an FDA correspondence related to the classification of a medical device (AllerSharp™ Allergy Skin Tester) and does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested table and paragraphs based on the given input.

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