Epi proColon
FDA premarket approval P130001/S005 · decided 2019-08-30
Approval details
- PMA number
- P130001
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2019-08-06
- Decision date
- 2019-08-30
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Change of storage and distribution facility.
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