Sun-Kit
Country not established
- Devices
- 1
What Sun-Kit makes
Sun-Kit manufactures the RA-80 Positive Control, a device used as a reference standard for validating diagnostic testing processes, ensuring accuracy and reliability in laboratory procedures.
The RA-80 Positive Control 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
Ra-80 Positive Control Ref K813309
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sun-Kit have in the registry?
The registry currently lists 1 device for Sun-Kit. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sun-Kit's devices?
Among its 1 most recently registered device, Sun-Kit has devices listed in FDA 510(k) (1 device).
What risk classes do Sun-Kit's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sun-Kit's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sun-Kit in the registry?
The most recently registered devices listed for Sun-Kit include RA-80 POSITIVE CONTROL.