Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032518803

FEI Number

3032518803

Entity Name

NEW DAY DIAGNOSTICS

City/State/Country

Knoxville, TN, US

Establishment Address

2730 Cherokee Farm Way Ste 300, Knoxville, TN 37920, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

New Day Diagnostics (Owner Number: 10093517)

Owner / Operator Contact Address

2730 Cherokee Farm Way Ste 300, Knoxville, TN 37920, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P130001

All Registered Proprietary Names

ColoHealth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2025-05-28

Official Correspondent

Eric Mayer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New Day Diagnostics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032518803. Last updated year: 2026. Please use registration number 3032518803 when referencing this establishment in official correspondence.