510(k) K250513
- Device
- IntelliSep Test (CV-ICG-048)
- Applicant
- Cytovale, Inc.
- 510(k) number
- K250513
- Product code
- QUT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-21
- Date received
- 2025-02-21
- Regulation
- 866.3215
- Classification name
- Deformability Cytometry For Sepsis Risk Assessment
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sarah Esterquest
- Address
- 2 Tower Pl. 18th Floor South San Francisco CA US 94404 94404
FDA Registration Numbers#
- 3005288662
- 3005370583
- 3017448032
- 3010423292