BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HER2/ER/PR IHControls® - Level M

    Reg #: 3023212278 · FEI: 3023212278 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOSTON CELL STANDARDS INC
    Registration Number
    3023212278
    FEI Number
    3023212278
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    800 Washington Street, Ziskind 417
    City
    Boston
    State
    MA
    ZIP
    02111
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220163

    Owner / Operator

    Firm Name
    Boston Cell Standards Inc
    Operator Number
    10086004
    Address
    800 Washington Street, Ziskind 417
    City
    Boston
    State
    MA
    Postal Code
    02111
    Country
    US
    Correspondent
    Steve Bogen

    Products

    Device Name Product Code
    Control Material, Her-2/Neu, Immunohistochemistry NJW

    Proprietary Names

    HER2/ER/PR IHControls® - Level M HER2/ER/PR IHControls® - Level L HER2/ER/PR IHControls® - Level H

    Establishment Types

    Manufacture Medical Device