Data / Medical devices / United States / New Day Diagnostics
New Day Diagnostics: FDA-registered device maker in Knoxville, TN, United States, 1 PMA approval
New Day Diagnostics is registered with the FDA (registration 3032518803) in Knoxville, TN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032518803
- Address
- 2730 Cherokee Farm Way Ste 300, Knoxville, TN, United States, 37920
- Owner or operator
- New Day Diagnostics (10093517)
- Roles
- Specification developer
- First device listed
- May 28, 2025
- Registered through
- 2026
- Brand names listed
- ColoHealth
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | 3 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 12, 2016 | P130001 | Epi proColon | PHP | 6 | March 19, 2025 | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.