Luchem Pharmaceuticals, Inc.
Country not established
- Devices
- 1
What Luchem Pharmaceuticals, Inc. makes
Luchem Pharmaceuticals, Inc. manufactures CHEM-DIALYTE CONCENTRATES, which are used as components in hemodialysis solutions to remove waste and excess fluids from the blood of patients with kidney failure.
These products are regulated as Class II medical devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Chem-Dialyte Concentrates Ref K810527
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Luchem Pharmaceuticals, Inc. have in the registry?
The registry currently lists 1 device for Luchem Pharmaceuticals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Luchem Pharmaceuticals, Inc.'s devices?
Among its 1 most recently registered device, Luchem Pharmaceuticals, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Luchem Pharmaceuticals, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Luchem Pharmaceuticals, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Luchem Pharmaceuticals, Inc. in the registry?
The most recently registered devices listed for Luchem Pharmaceuticals, Inc. include CHEM-DIALYTE CONCENTRATES.