510(k) K220991 ยท QUT Deformability Cytometry For Sepsis Risk Assessment
IntelliSep test
| Applicant | Cytovale, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 20, 2022 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220991
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.