510(k) K260827 · SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Oncomine Dx Express Test
| Applicant | Life Technologies Corporation, Frederick MD, US |
| Decision | Substantially Equivalent, Oct 15, 2026 |
| Received | Mar 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260827
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.