BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FoundationOne CDx

    Reg #: 3010679023 · FEI: 3010679023 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FOUNDATION MEDICINE, INC.
    Registration Number
    3010679023
    FEI Number
    3010679023
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 Second St, 1st Floor
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US

    Regulatory Submissions

    PMA Number
    P170019

    Owner / Operator

    Firm Name
    Foundation Medicine, Inc.
    Operator Number
    10053707
    Address
    150 Second St
    City
    Cambridge
    State
    MA
    Postal Code
    02141
    Country
    US
    Correspondent
    Ryan Woodhouse

    Products

    Device Name Product Code
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP

    Proprietary Names

    FoundationOne CDx

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198