PMA P250029
- Device
- SimpleScreen™ CRC
- Applicant
- Freenome, LLC
- PMA number
- P250029
- Supplement
- S001
- Product code
- PHP
- Decision date
- 2026-08-26
- Classification
- Medical Genetics
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- changes in a supplier manufacturing processes for critical reagents
Current openFDA PMA Record#
- Device
- SimpleScreen™ CRC
- Applicant
- Freenome, LLC
- PMA number
- P250029
- Supplement
- S001
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2026-08-26
- Decision code
- OK30
- Date received
- 2026-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes in a supplier manufacturing processes for critical reagents