GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is an AI-enabled medical device from Geneseeq Technology Inc., listed by FDA (510(k), K250003) with a decision date of 2025-08-29. Review panel: Pathology.
| FDA submission number | K250003 |
|---|---|
| Pathway | 510(k) |
| Company | Geneseeq Technology Inc. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2025-08-29 |
| Decision | Substantially Equivalent |
| Product code | PZM |
| Classification | Next Generation Sequencing Based Tumor Profiling Test |
| Device class | 2 |
| Regulation number | 866.6080 |
| Review time (calendar days) | 239 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.