510(k) K250912 ยท QUT Deformability Cytometry For Sepsis Risk Assessment
IntelliSep Test
| Applicant | Cytovale, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Nov 19, 2025 |
| Received | Mar 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250912
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.