PMA P130001S004
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S004
- Product code
- PHP
- Decision date
- 2018-03-20
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Addition of alternate suppliers of key reagents for the test system.
Current openFDA PMA Record#
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S004
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2018-03-20
- Decision code
- OK30
- Date received
- 2018-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate suppliers of key reagents for the test system.