DEN230036
- 510(k) number
- DEN230036
- Device name
- Sepsis ImmunoScore
- Applicant
- Prenosis, Inc. IL · US
- Product code
- SAK — Software Device To Aid In The Prediction Or Diagnosi
- Decision date
- 2024-04-02
- Date received
- 2023-05-05
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN230036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.