PMA P130001
- Device
- ColoHealth
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S007
- Product code
- PHP
- Decision date
- 2025-03-19
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Approval for the rebranding of the medical device previously known as Epi proColon® to ColoHealth™.
Current openFDA PMA Record#
- Device
- ColoHealth
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S009
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2025-03-19
- Decision code
- APPR
- Date received
- 2024-10-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the rebranding of the medical device previously known as Epi proColon® to ColoHealth™.