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510(k) Data Aggregation

    K Number
    K183140
    Device Name
    MTS Tetracycline 0.016 - 256 ug/mL
    Manufacturer
    Liofilchem s.r.l.
    Date Cleared
    2019-01-11

    (59 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "MTS Tetracycline 0.016 - 256 ug/mL" which is an antimicrobial susceptibility test powder. This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot provide the requested information based on the given input. The document is primarily a regulatory clearance letter and does not delve into the technical details of the validation study.

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