BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiacs II Control

    Reg #: 2022375 · FEI: 2022375 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UTAK LABORATORIES, INC.
    Registration Number
    2022375
    FEI Number
    2022375
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25020 AVENUE TIBBITTS
    City
    VALENCIA
    State
    CA
    ZIP
    91355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K800884

    Owner / Operator

    Firm Name
    UTAK LABORATORIES, I
    Operator Number
    2022375
    Address
    25020 AVENUE TIBBITTS, --
    City
    Valencia
    State
    CA
    Postal Code
    91355
    Country
    US
    Correspondent
    Kevin M Kopp

    Products

    Device Name Product Code
    Drug Mixture Control Materials DIF

    Proprietary Names

    Cardiacs II Control

    Establishment Types

    Manufacture Medical Device