Stat Chem, Inc.
Country not established
- Devices
- 1
What Stat Chem, Inc. makes
Stat Chem, Inc. manufactures the STAT K in vitro diagnostic test system, a device used for rapid biochemical analysis of blood or serum samples to measure potassium levels.
The STAT K system is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Stat K In Vitro Diagnostic Test System Ref K042270
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stat Chem, Inc. have in the registry?
The registry currently lists 1 device for Stat Chem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stat Chem, Inc.'s devices?
Among its 1 most recently registered device, Stat Chem, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Stat Chem, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Stat Chem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stat Chem, Inc. in the registry?
The most recently registered devices listed for Stat Chem, Inc. include STAT K IN VITRO DIAGNOSTIC TEST SYSTEM.