BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Roche ISETROL Control

    Reg #: 1220649 · FEI: 1220649 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIONOSTICS, INC.
    Registration Number
    1220649
    FEI Number
    1220649
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 JACKSON RD.
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K880710

    Owner / Operator

    Firm Name
    BIONOSTICS, INC.
    Operator Number
    1220649
    Address
    7 JACKSON RD., --
    City
    Devens
    State
    MA
    Postal Code
    01434
    Country
    US
    Correspondent
    Yifei Wang

    Products

    Device Name Product Code
    Electrolyte Controls (Assayed And Unassayed) JJR

    Proprietary Names

    Roche ISETROL Control OPTI Medical OPTI-Check Lytes Control

    Establishment Types

    Manufacture Medical Device