FDA Product Code
FDA Product Code PLQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5985
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025-04-17 | Traditional | PDF ↗ |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025-01-15 | Traditional | PDF ↗ |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023-12-21 | Traditional | PDF ↗ |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023-08-30 | Traditional | PDF ↗ |
| K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019-12-04 | Traditional | PDF ↗ |
| K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017-07-12 | Traditional | PDF ↗ |
| K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016-06-30 | Traditional | PDF ↗ |
| DEN150001 | RELIZORB | Alcresta, Inc. | 2015-11-20 | Direct | — |
Product code PLQ · Class II · Gastroenterology, Urology. Data: openFDA.