BEUDAMED
    FDA Registration Active 🇺🇸 United States

    oncoFISH her2

    Reg #: 3005566046 · FEI: 3005566046 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ikonisys, Inc
    Registration Number
    3005566046
    FEI Number
    3005566046
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Science Park
    City
    New Haven
    State
    CT
    ZIP
    06511
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080909

    Owner / Operator

    Firm Name
    Ikonisys, Inc
    Operator Number
    10023706
    Address
    5 Science Park
    City
    New Haven
    State
    CT
    Postal Code
    06511
    Country
    US
    Correspondent
    Michael Kilpatrick

    Products

    Device Name Product Code
    System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays NTH

    Proprietary Names

    oncoFISH her2

    Establishment Types

    Manufacture Medical Device