Aktiebolaget Leo Diagnostics
Country not established
- Devices
- 1
What Aktiebolaget Leo Diagnostics makes
The company produces photometric analyzers, specifically the Hemocue photometer series, designed for measuring hemoglobin levels in blood samples. These devices are intended for use in clinical and point-of-care settings to provide rapid, accurate results for diagnostic purposes.
The portfolio is regulated as Class II medical devices under the FDA’s 510(k) clearance pathway. These devices are listed in the U.S. regulatory database and are manufactured by a company based in the United States.
Catalogue
Hemocue Photometer Technical Manual Ref K832020
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aktiebolaget Leo Diagnostics have in the registry?
The registry currently lists 1 device for Aktiebolaget Leo Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aktiebolaget Leo Diagnostics's devices?
Among its 1 most recently registered device, Aktiebolaget Leo Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Aktiebolaget Leo Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Aktiebolaget Leo Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aktiebolaget Leo Diagnostics in the registry?
The most recently registered devices listed for Aktiebolaget Leo Diagnostics include HEMOCUE PHOTOMETER TECHNICAL MANUAL.