BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    APAS Independence with MRSA Analysis Module

    Reg #: 3023339158 · FEI: 3023339158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LBT INNOVATIONS LIMITED
    Registration Number
    3023339158
    FEI Number
    3023339158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16 Anster St
    City
    Adelaide South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K200839

    Owner / Operator

    Firm Name
    LBT Innovations Limited
    Operator Number
    10085613
    Address
    16 Anster St
    City
    Adelaide
    State
    South Australia
    Postal Code
    5000
    Country
    AU
    Correspondent
    Julie A Winson

    US Agent

    Business Name
    Planet Innovation
    Contact Name
    Krystal Santiago
    Address
    80 Technology Drive
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2381200

    Products

    Device Name Product Code
    Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms QQY

    Proprietary Names

    APAS Independence with MRSA Analysis Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility