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510(k) Data Aggregation

    K Number
    K990998
    Device Name
    POLYSLIT IFE KIT
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1999-06-28

    (95 days)

    Product Code
    CFF
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This kit is intended for the separation of immunoglobulins using agarose gel electrophoresis. This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such which cypically Chilbre annual collagen disorders and other chronic infections.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter from the FDA for a device called "Polyslit IFE Kit," and it doesn't contain information about acceptance criteria or a study proving that a device meets those criteria, as it's not a performance evaluation report. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the requested information from the provided text.

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