xT CDx
FDA premarket approval P210011/S003 · decided 2025-06-27
Approval details
- PMA number
- P210011
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- xT CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Tempus AI, Inc.
- Date received
- 2025-04-01
- Decision date
- 2025-06-27
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- This Real-Time PMA Supplement is for approval of stability protocols for reagents and probes used with xT CDx.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| xR IVD (K241868) | Tempus AI, Inc. | 2025-09-19 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| Tempus ECG-AF (K233549) | Tempus AI, Inc. | 2024-06-21 |