510(k) K202304 ยท PZM Next Generation Sequencing Based Tumor Profiling Test
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
| Applicant | Nyu Langone Medical Center, New York NY, US |
| Decision | Substantially Equivalent, Jul 14, 2021 |
| Received | Aug 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202304
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.