Alcresta Therapeutics, Inc.
United StatesFDA applicant, unverified FDA FEI 3009596666
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
RELiZORB (100300/ 100301) Ref K243284
Regimes: 510(k) Registry: 510(k)RELiZORB Ref K191379
Regimes: 510(k) Registry: 510(k)RELiZORB® Ref K232784
Regimes: 510(k) Registry: 510(k)Relizorb Ref K163057
Regimes: 510(k) Registry: 510(k)Relizorb Ref K161247
Regimes: 510(k) Registry: 510(k)RELiZORB (100300/100301) Ref K250499
Regimes: 510(k) Registry: 510(k)Enzyme Packed Cartridge - RELiZORB Ref K231156
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009596666
- DUNS number
- 078683247
- Address
- 130 Turner Street, Waltham, MA, 02453
- Website
- www.alcresta.com
- linkedin.com/company/10674874
- [email protected]
- Phone
- 6177149946
From the company website
Alcresta develops rare disease, enzyme-based products helping to address fat malabsorption (often due to exocrine pancreatic insufficiency) in patients who are enterally fed at home or in the hospital. Our RELiZORB® cartridge contains iLipase®, a patented microbead/enzyme technology that breaks down fat for easy ingestion and optimal absorption.
Frequently asked questions
How many devices does Alcresta Therapeutics, Inc. have in the registry?
The registry currently lists 10 devices for Alcresta Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alcresta Therapeutics, Inc.'s devices?
Among its 10 most recently registered devices, Alcresta Therapeutics, Inc. has devices listed in FDA 510(k) (7 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alcresta Therapeutics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Alcresta Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alcresta Therapeutics, Inc. in the registry?
The most recently registered devices listed for Alcresta Therapeutics, Inc. include RELiZORB 200209 / 200211, Relizorb 100103, RELiZORB 100300/100301 and RELiZORB (100300/ 100301).