Epi proColon
FDA premarket approval P130001/S002 · decided 2016-10-18
Approval details
- PMA number
- P130001
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Epi proColon
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- New Day Diagnostics, LLC
- Date received
- 2016-05-10
- Decision date
- 2016-10-18
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Approval of the post-approval study protocol.
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