Epi proColon
FDA premarket approval P130001/S001 · decided 2016-11-18
Approval details
- PMA number
- P130001
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Epi proColon
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- New Day Diagnostics, LLC
- Date received
- 2016-04-29
- Decision date
- 2016-11-18
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Approval for a manufacturing site located at Sentinel CH. SpA, Via Robert Koch, 2, 20152, Milan, Italy
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