xT CDx
FDA premarket approval P210011/S001 · decided 2023-06-07
Approval details
- PMA number
- P210011
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- xT CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Tempus AI, Inc.
- Date received
- 2023-05-22
- Decision date
- 2023-06-07
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- Addition of an alternate specimen collection kit assembly and distribution supplier.
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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 |