510(k) K241868 ยท PZM Next Generation Sequencing Based Tumor Profiling Test
xR IVD
| Applicant | Tempus AI, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Jun 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241868
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.