LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183298
    Device Name
    HardyDisk AST Omadacycline 30µg (OMC30)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2019-01-18

    (52 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    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

    This is a clearance letter for a medical device called "HardyDisk AST Omadacycline 30μg (OMC30)". This document does not describe the acceptance criteria or a study to prove the device meets acceptance criteria. It mentions that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1