Diamond Sensor Systems
Country not established
- Devices
- 3
What Diamond Sensor Systems makes
Diamond Sensor Systems manufactures blood gas and electrolyte analysis systems, including portable and benchtop devices for measuring critical parameters like pH, pCO₂, pO₂, and electrolytes. These systems are designed for use in clinical, emergency, and point-of-care settings, supporting rapid diagnostic assessments. The portfolio includes standalone analyzers and integrated systems with consumable cartridges for sample testing.
The company’s devices are regulated under FDA’s 510(k) clearance process, with products classified as Class I and Class II medical devices. The portfolio is listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Gem-Crit Check Ref K871686
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Gem-Stat, Gem-Pak 2, Gem-Check, Gem-Crit Check Ref K873577
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diamond Sensor Systems have in the registry?
The registry currently lists 3 devices for Diamond Sensor Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diamond Sensor Systems's devices?
Among its 3 most recently registered devices, Diamond Sensor Systems has devices listed in FDA 510(k) (3 devices).
What risk classes do Diamond Sensor Systems's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diamond Sensor Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diamond Sensor Systems in the registry?
The most recently registered devices listed for Diamond Sensor Systems include GEM-CRIT CHECK, GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. and GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK.