European Concerted Action on Anticoagulation
United KingdomFDA applicant, unverified
- Devices
- 1
What European Concerted Action on Anticoagulation makes
The company manufactures Poller Calibrants, which are reference standards used to calibrate and validate anticoagulation monitoring devices, ensuring accurate measurement of blood clotting times.
These devices fall under FDA Class II regulation and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Poller Calibrants Ref K991439
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does European Concerted Action on Anticoagulation have in the registry?
The registry currently lists 1 device for European Concerted Action on Anticoagulation. Devices recorded under merged duplicate company entries are counted once.
Which registries list European Concerted Action on Anticoagulation's devices?
Among its 1 most recently registered device, European Concerted Action on Anticoagulation has devices listed in FDA 510(k) (1 device).
What risk classes do European Concerted Action on Anticoagulation's devices fall under?
Among its 1 most recently registered device, the classes recorded for European Concerted Action on Anticoagulation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from European Concerted Action on Anticoagulation in the registry?
The most recently registered devices listed for European Concerted Action on Anticoagulation include POLLER CALIBRANTS.