BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sofia2

    Reg #: 2022994 · FEI: 2022994 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Planet Innovation Products, Inc.
    Registration Number
    2022994
    FEI Number
    2022994
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    80 Technology Drive
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162911

    Owner / Operator

    Firm Name
    Planet Innovation Products, Inc.
    Operator Number
    9063957
    Address
    80 Technology Drive, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Krystal Santiago

    Products

    Device Name Product Code
    Fluorometer, For Clinical Use KHO

    Proprietary Names

    Sofia2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)