BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Color Cancer FIT IO

    Reg #: 3011845225 · FEI: 3011845225 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLOR DIAGNOSTICS, LLC
    Registration Number
    3011845225
    FEI Number
    3011845225
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    863 Mitten Road, Suite 100F
    City
    Burlingame
    State
    CA
    ZIP
    94010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191147

    Owner / Operator

    Firm Name
    Color Diagnostics, LLC
    Operator Number
    10086172
    Address
    863 Mitten Road, Suite 100F
    City
    Burlingame
    State
    CA
    Postal Code
    94010
    Country
    US
    Correspondent
    FDA Team

    Products

    Device Name Product Code
    Automated Occult Blood Analyzer OOX

    Proprietary Names

    Color Cancer FIT IO

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility