Karolinski
SwedenFDA applicant, unverified
- Devices
- 1
What Karolinski makes
Karolinski manufactures EDTA CAVIT, a medical device designed for specific diagnostic or therapeutic procedures involving blood collection or analysis.
The EDTA CAVIT falls under FDA Class II regulation and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Edta Cavit Ref K970246
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karolinski have in the registry?
The registry currently lists 1 device for Karolinski. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karolinski's devices?
Among its 1 most recently registered device, Karolinski has devices listed in FDA 510(k) (1 device).
What risk classes do Karolinski's devices fall under?
Among its 1 most recently registered device, the classes recorded for Karolinski's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karolinski in the registry?
The most recently registered devices listed for Karolinski include EDTA CAVIT.