ColoHealth
FDA premarket approval P130001/S009 · decided 2025-03-19
Approval details
- PMA number
- P130001
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ColoHealth
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- New Day Diagnostics, LLC
- Date received
- 2024-10-01
- Decision date
- 2025-03-19
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Approval for the rebranding of the medical device previously known as Epi proColon® to ColoHealth.
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