- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- PMA number
- P200010
- Supplement
- S016
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2024-03-18
- Decision code
- APPR
- Date received
- 2023-11-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for upgrading Guardant360CDx software sub-component Bioinformatics Pipeline (BIP) software from v3.5.4 to v3.5.5