BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Phoenix ISE Standards for Roche AVL 982,983,984,985,986,987,988,9110/9140,9120/9130,9180/9181

    Reg #: 1222035 · FEI: 1222035 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHOENIX DIAGNOSTICS, INC.
    Registration Number
    1222035
    FEI Number
    1222035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 TECH CIRCLE
    City
    Natick
    State
    MA
    ZIP
    01760
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023268

    Owner / Operator

    Firm Name
    PHOENIX DIAGNOSTICS, INC.
    Operator Number
    1222035
    Address
    8 TECH CIRCLE, --
    City
    Natick
    State
    MA
    Postal Code
    01760
    Country
    US
    Correspondent
    RAM - NUNNA

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    Phoenix ISE Standards for Roche AVL 982,983,984,985,986,987,988,9110/9140,9120/9130,9180/9181

    Establishment Types

    Manufacture Medical Device