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510(k) Data Aggregation

    K Number
    K970149
    Device Name
    LEGIONELLA ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1997-06-18

    (154 days)

    Product Code
    LHL
    Regulation Number
    866.3300
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeus Scientific, Inc. Legionella ELISA test system is intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum. The test system is intended to be used as an aid in the diagnosis of Legionella-related infections. This test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe these details.

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