K241868
- 510(k) number
- K241868
- Device name
- xR IVD
- Applicant
- Tempus AI, Inc. IL · US
- Product code
- PZM — Next Generation Sequencing Based Tumor Profiling Tes
- Decision date
- 2025-09-19
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K241868.pdf
Official FDA record: K241868
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.