Cardea Associates, Inc.
Country not established
- Devices
- 1
What Cardea Associates, Inc. makes
Cardea Associates, Inc. manufactures CARDEASCREEN, a diagnostic device used for screening and detecting specific cardiac conditions through blood-based testing.
The company’s portfolio is regulated under FDA’s Class II device classification, with CARDEASCREEN authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Cardeascreen Ref K123217
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardea Associates, Inc. have in the registry?
The registry currently lists 1 device for Cardea Associates, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardea Associates, Inc.'s devices?
Among its 1 most recently registered device, Cardea Associates, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cardea Associates, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardea Associates, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardea Associates, Inc. in the registry?
The most recently registered devices listed for Cardea Associates, Inc. include CARDEASCREEN.