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510(k) Data Aggregation

    K Number
    K972387
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP A
    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 A

    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) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms the device (VISTA™ Antigen Salmonella O Group A) has been found substantially equivalent to a predicate device for its stated 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 provided text.

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