Alden Scientific, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Alden Scientific, Inc. makes
Alden Scientific, Inc. manufactures medical devices including NEPHRETECT and GLUTATECT, which are designed for specific renal and metabolic applications. These products are intended for use in clinical settings to address targeted medical conditions related to kidney function and glucose metabolism.
The company’s portfolio is regulated under FDA Class II devices, with products authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Nephretect Ref K934066
Regimes: 510(k) Registry: 510(k)Glutatect Ref K971888
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alden Scientific, Inc. have in the registry?
The registry currently lists 2 devices for Alden Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alden Scientific, Inc.'s devices?
Among its 2 most recently registered devices, Alden Scientific, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Alden Scientific, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Alden Scientific, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alden Scientific, Inc. in the registry?
The most recently registered devices listed for Alden Scientific, Inc. include NEPHRETECT and GLUTATECT.