IntelliSep Test
FDA 510(k) clearance K250912 · decided 2025-11-19
Clearance details
- K-number
- K250912
- Device name
- IntelliSep Test
- Applicant
- Cytovale, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-27
- Decision date
- 2025-11-19
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- QUT
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- South San Francisco, CA, 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 |
|---|---|---|
| IntelliSep Test (CV-ICG-048) (K250513) | Cytovale, Inc. | 2025-03-21 |
| IntelliSep test (K220991) | Cytovale, Inc. | 2022-12-20 |
Recalls involving this device
No recalls on record reference this clearance.