Renalchem, Inc.
Country not established
- Devices
- 1
What Renalchem, Inc. makes
Renalchem, Inc. manufactures hemodialysis concentrates in various formulations, including liquid hemodialysis concentrate additives designed for use in renal replacement therapies.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Renalchem, Inc. have in the registry?
The registry currently lists 1 device for Renalchem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Renalchem, Inc.'s devices?
Among its 1 most recently registered device, Renalchem, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Renalchem, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Renalchem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Renalchem, Inc. in the registry?
The most recently registered devices listed for Renalchem, Inc. include HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD.