BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Antigen Plus

    Reg #: 3009768528 · FEI: 3009768528 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROWNY SYSTEMS, INC.
    Registration Number
    3009768528
    FEI Number
    3009768528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    166 Gold Kettle Dr
    City
    Gaithersburg
    State
    MD
    ZIP
    20878
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK110045

    Owner / Operator

    Firm Name
    Rowny Systems, Inc.
    Operator Number
    10041559
    Address
    6508 81st St.
    City
    Cabin John
    State
    MD
    Postal Code
    20818
    Country
    US
    Correspondent
    Alan K Martinson

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    Antigen Plus

    Establishment Types

    Manufacture Medical Device