PMA P200010S031
- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- PMA number
- P200010
- Supplement
- S031
- Product code
- PQP
- Decision date
- 2026-07-06
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- modification of the incoming acceptance process for a non-critical component
Current openFDA PMA Record#
- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- PMA number
- P200010
- Supplement
- S031
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-07-06
- Decision code
- OK30
- Date received
- 2026-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modification of the incoming acceptance process for a non-critical component