BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ColoHealth

    Reg #: 3032518803 · FEI: 3032518803 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEW DAY DIAGNOSTICS
    Registration Number
    3032518803
    FEI Number
    3032518803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6701 Baum Dr Ste 110
    City
    Knoxville
    State
    TN
    ZIP
    37919
    Country
    US

    Regulatory Submissions

    PMA Number
    P130001

    Owner / Operator

    Firm Name
    New Day Diagnostics
    Operator Number
    10093517
    Address
    6701 Baum Dr., Suite 110
    City
    Knoxville
    State
    TN
    Postal Code
    37919
    Country
    US
    Correspondent
    Eric Mayer

    Products

    Device Name Product Code
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection PHP

    Proprietary Names

    ColoHealth

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device