BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CellTracks Analyzer II®

    Reg #: 3004153557 · FEI: 3004153557 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Menarini Silicon Biosystems Inc.
    Registration Number
    3004153557
    FEI Number
    3004153557
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3401 Masons Mill road, Suite 100
    City
    Huntingdon Valley
    State
    PA
    ZIP
    19006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130794

    Owner / Operator

    Firm Name
    Menarini Silicon Biosystems Inc.
    Operator Number
    10054393
    Address
    3401 Masons Mill Road, Suite 100
    City
    Huntingdon Valley
    State
    PA
    Postal Code
    19006
    Country
    US
    Correspondent
    Thomas Johnson

    Products

    Device Name Product Code
    System, Immunomagnetic, Circulating Cancer Cell, Enumeration NQI

    Proprietary Names

    CellTracks Analyzer II®

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198