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510(k) Data Aggregation

    K Number
    K972395
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP D
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VISTA ANTIGEN SALMONELLA O GROUP D

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

    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the VISTA™ Antigen Salmonella O Group D device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    The letter primarily covers:

    • The FDA's determination of substantial equivalence for the device.
    • Regulatory classifications and general controls applicable to the device.
    • Contact information for further regulatory guidance.
    • An enclosure indicating the device's indications for use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

    Therefore, I cannot provide the requested information based on the given document.

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