BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PixoTest

    Reg #: 3017548799 · FEI: 3017548799 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    iXensor Corp.
    Registration Number
    3017548799
    FEI Number
    3017548799
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2710 Sand Hill Rd.
    City
    Menlo Park
    State
    CA
    ZIP
    94025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181915

    Owner / Operator

    Firm Name
    iXensor Co Ltd
    Operator Number
    10048224
    Address
    11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,
    City
    Taipei
    State
    TW-TPE
    Postal Code
    114
    Country
    TW

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    PixoTest

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198