510(k) K192063 ยท PZM Next Generation Sequencing Based Tumor Profiling Test
PGDx elio tissue complete
| Applicant | Personal Genome Diagnostics, Baltimore MD, US |
| Decision | Substantially Equivalent, Apr 24, 2020 |
| Received | Aug 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192063
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.