PMA P200010S014
- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- Product code
- PQP
- Decision date
- 2023-05-16
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Add component manufacturing at Guardants facility.
Current openFDA PMA Record
- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- PMA number
- P200010
- Supplement
- S014
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2023-05-16
- Decision code
- OK30
- Date received
- 2023-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add component manufacturing at Guardants facility.