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510(k) Data Aggregation

    K Number
    K972389
    Device Name
    VISTA ANTIGEN SALMONELLA H 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 H 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

    This document is a 510(k) premarket notification letter from the FDA regarding the VISTA™ Antigen Salmonella H d. It grants market clearance for the device based on substantial equivalence to a predicate device.

    Crucially, this document does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any mention of AI or standalone algorithm performance.

    Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval, not a scientific study report.

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