PLQ
8 FDA 510(k) clearances · Product code
128 daysmedian time to decision
322 days90th percentile
8clearances measured
FDA profile
- Official device name
- Enzyme Packed Cartridge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5985
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Hydrolyze fats in enteral formula.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RELiZORB (100300/100301) (K250499) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| RELiZORB (100300/ 100301) (K243284) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| RELiZORB® (K232784) | Alcresta Therapeutics, Inc. | 2023-12-21 |
| Enzyme Packed Cartridge - RELiZORB (K231156) | Alcresta Therapeutics, Inc. | 2023-08-30 |
| RELiZORB (K191379) | Alcresta Therapeutics, Inc. | 2019-12-04 |
| Relizorb (K163057) | Alcresta Therapeutics, Inc. | 2017-07-12 |
| Relizorb (K161247) | Alcresta Therapeutics, Inc. | 2016-06-30 |
| RELIZORB (DEN150001) | Alcresta, Inc. | 2015-11-20 |
Track PLQ automatically
Every clearance here is in the API, with alerts when new ones post.