Haemolyte, Inc.
Country not established
- Devices
- 1
What Haemolyte, Inc. makes
Haemolyte, Inc. manufactures bicarbonate concentrate powder, a medical-grade formulation intended for intravenous administration to correct metabolic acidosis in clinical settings.
The company’s portfolio is regulated under FDA’s Class II device classification, with products listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Bicarbonate Concentrate Powder Ref K891921
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haemolyte, Inc. have in the registry?
The registry currently lists 1 device for Haemolyte, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haemolyte, Inc.'s devices?
Among its 1 most recently registered device, Haemolyte, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Haemolyte, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Haemolyte, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haemolyte, Inc. in the registry?
The most recently registered devices listed for Haemolyte, Inc. include BICARBONATE CONCENTRATE POWDER.