IntelliSep test
FDA 510(k) clearance K220991 · decided 2022-12-20
Clearance details
- K-number
- K220991
- Device name
- IntelliSep test
- Applicant
- Cytovale, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2022-12-20
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- QUT
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cytovale
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IntelliSep Test (K250912) | Cytovale, Inc. | 2025-11-19 |
| IntelliSep Test (CV-ICG-048) (K250513) | Cytovale, Inc. | 2025-03-21 |
Recalls involving this device
No recalls on record reference this clearance.