PBC Separator with Selux AST System
FDA 510(k) clearance K244044 · decided 2025-03-28
Clearance details
- K-number
- K244044
- Device name
- PBC Separator with Selux AST System
- Applicant
- Selux Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-30
- Decision date
- 2025-03-28
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- QZX
- Device class
- 2
- Regulation number
- 866.1650
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Charlestown, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Selux Diagnostics
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 |
|---|---|---|
| PBC Separator with Selux AST System (K223493) | Selux Diagnostics, Inc. | 2024-02-15 |
| eQUANT System (K231536) | Avails Medical, Inc. | 2024-02-08 |
Recalls involving this device
No recalls on record reference this clearance.