Data / Medical devices / United States / Alcresta Therapeutics, Inc.
Alcresta Therapeutics, Inc.: FDA-registered device maker in Waltham, MA, United States, 3 510(k) clearances
Alcresta Therapeutics, Inc. is registered with the FDA (registration 3009596666) in Waltham, MA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 17, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009596666
- Address
- 130 Turner Street Building 3, Suite 200, Waltham, MA, United States, 02453
- Owner or operator
- Alcresta Therapeutics, Inc. (10050687)
- Roles
- Manufacturer
- First device listed
- May 6, 2024
- Registered through
- 2027
- Brand names listed
- RELiZORB
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Packed Cartridge | PLQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2025 | K250499 | RELiZORB (100300/100301) | PLQ | Substantially Equivalent | Alcresta Therapeutics, Inc. | accessdata.fda.gov |
| January 15, 2025 | K243284 | RELiZORB (100300/ 100301) | PLQ | Substantially Equivalent | Alcresta Therapeutics, Inc. | accessdata.fda.gov |
| December 21, 2023 | K232784 | RELiZORB® | PLQ | Substantially Equivalent | Alcresta Therapeutics, Inc. | accessdata.fda.gov |
Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.