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510(k) Data Aggregation

    K Number
    K010328
    Device Name
    MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
    Manufacturer
    IZON BUSINESS PRODUCTS, INC.
    Date Cleared
    2001-04-09

    (66 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    IZON BUSINESS PRODUCTS, INC.

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

    A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.

    Device Description

    A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.

    AI/ML Overview

    I apologize, but the provided text describes a 510(k) clearance letter for a DNA Blood Collection Kit and does not contain information about acceptance criteria or a study proving device performance as requested. It is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the input provided.

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