BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Remel Cleveland, A Division of Remel Inc.

    Reg #: 1530126 · FEI: 1000515493 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Remel Cleveland, A Division of Remel Inc.
    Registration Number
    1530126
    FEI Number
    1000515493
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Thermo Fisher Way
    City
    Oakwood Village
    State
    OH
    ZIP
    44146
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133038

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Susceptibility Test Plate, Antifungal NGZ

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility