Sepsis ImmunoScore
FDA 510(k) clearance DEN230036 · decided 2024-04-02
Clearance details
- K-number
- DEN230036
- Device name
- Sepsis ImmunoScore
- Applicant
- Prenosis, Inc.
- Decision
- Unknown
- Date received
- 2023-05-05
- Decision date
- 2024-04-02
- Days to decision
- 333 days
- Clearance type
- Direct
- Product code
- SAK
- Device class
- 2
- Regulation number
- 880.6316
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bayesian Health Sepsis Flagging Device (K250680) | Bayesian Health, Inc. | 2026-04-30 |
Recalls involving this device
No recalls on record reference this clearance.