Epi proColon
FDA premarket approval P130001/S004 · decided 2018-03-20
Approval details
- PMA number
- P130001
- Supplement
- S004
- 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
- 2018-02-20
- Decision date
- 2018-03-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Addition of alternate suppliers of key reagents for the test system.
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