510(k) K220991
- Device
- IntelliSep test
- Applicant
- Cytovale, Inc.
- 510(k) number
- K220991
- Product code
- QUT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-20
- Date received
- 2022-04-04
- Regulation
- 866.3215
- Classification name
- Deformability Cytometry For Sepsis Risk Assessment
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Juliet Carrara
- Address
- 150 Executive Park Blvd., Suite 4100 San Francisco CA US 94134 94134
FDA Registration Numbers#
- 3005288662
- 3005370583
- 3017448032
- 3010423292