PMA P230009
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- Product code
- PHP
- Decision date
- 2026-10-05
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- approval of a secondary vendor
Current openFDA PMA Record#
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- PMA number
- P230009
- Supplement
- S021
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2026-10-05
- Decision code
- OK30
- Date received
- 2026-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a secondary vendor