PMA P130001S001
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S001
- Product code
- PHP
- Decision date
- 2016-11-18
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Approval for a manufacturing site located at Sentinel CH. SpA, Via Robert Koch, 2, 20152, Milan, Italy
Current openFDA PMA Record#
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S001
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2016-11-18
- Decision code
- APPR
- Date received
- 2016-04-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Sentinel CH. SpA, Via Robert Koch, 2, 20152, Milan, Italy