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510(k) Data Aggregation

    K Number
    K972390

    Validate with FDA (Live)

    Device Name
    VISTA ANTIGEN SALMONELLA H C
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 marketing clearance letter for the VISTA™ Antigen Salmonella H c device (K972390) and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the original 510(k) submission document or a summary of the clinical performance data.

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