PLQ
- Product code
- PLQ
- Device name
- Enzyme Packed Cartridge
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5985
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
Hydrolyze fats in enteral formula.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250499 | 2025-04-17 | Alcresta Therapeutics, Inc. | RELiZORB (100300/100301) | |
| K243284 | 2025-01-15 | Alcresta Therapeutics, Inc. | RELiZORB (100300/ 100301) | |
| K232784 | 2023-12-21 | Alcresta Therapeutics, Inc. | RELiZORB® |
Official FDA classification page: PLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).