BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spectra Optia Apheresis System

    Reg #: 1722028 · FEI: 1000117351 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT, Inc..
    Registration Number
    1722028
    FEI Number
    1000117351
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10811 W COLLINS AVE
    City
    Lakewood
    State
    CO
    ZIP
    80215
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK150251

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    Spectra Optia Apheresis System Spectra Optia IDL Set

    Establishment Types

    Manufacture Medical Device