510(k) K250513 ยท QUT Deformability Cytometry For Sepsis Risk Assessment
IntelliSep Test (CV-ICG-048)
| Applicant | Cytovale, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Feb 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250513
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.