PMA P210011
- Device
- xT CDx
- Applicant
- Tempus Labs, Inc.
- Product code
- PQP
- Decision date
- 2025-06-27
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- This Real-Time PMA Supplement is for approval of stability protocols for reagents and probes used with xT CDx.
Current openFDA PMA Record
- Device
- xT CDx
- Applicant
- Tempus Labs, Inc.
- PMA number
- P210011
- Supplement
- S003
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-06-27
- Decision code
- APPR
- Date received
- 2025-04-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- This Real-Time PMA Supplement is for approval of stability protocols for reagents and probes used with xT CDx.