PBC Separator with Selux AST System
FDA 510(k) clearance K223493 · decided 2024-02-15
Clearance details
- K-number
- K223493
- Device name
- PBC Separator with Selux AST System
- Applicant
- Selux Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-21
- Decision date
- 2024-02-15
- Days to decision
- 451 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
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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 |
|---|---|---|
| PBC Separator with Selux AST System (K244044) | Selux Diagnostics, Inc. | 2025-03-28 |
| eQUANT System (K231536) | Avails Medical, Inc. | 2024-02-08 |
Recalls involving this device
No recalls on record reference this clearance.