K250912
- 510(k) number
- K250912
- Device name
- IntelliSep Test
- Applicant
- Cytovale, Inc. CA · US
- Product code
- QUT — Deformability Cytometry For Sepsis Risk Assessment
- Decision date
- 2025-11-19
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250912.pdf
Official FDA record: K250912
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.