TriVerity is an AI-enabled medical device from Inflammatix, Inc., listed by FDA (510(k), K241676) with a decision date of 2025-01-10. Review panel: Microbiology.
| FDA submission number | K241676 |
|---|---|
| Pathway | 510(k) |
| Company | Inflammatix, Inc. |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2025-01-10 |
| Decision | Substantially Equivalent |
| Product code | PRE |
| Classification | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers |
| Device class | 2 |
| Regulation number | 866.3215 |
| Review time (calendar days) | 213 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Microbiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.