James Nguyen
Country not established
- Devices
- 1
What James Nguyen makes
James Nguyen manufactures the Wunder Pregnancy Test, a lateral flow immunoassay device designed for detecting human chorionic gonadotropin (hCG) in urine to confirm pregnancy.
The Wunder Pregnancy Test is classified as a Class II medical device in the US and is listed under FDA’s 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Wunder Pregnancy Test Ref K130456
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does James Nguyen have in the registry?
The registry currently lists 1 device for James Nguyen. Devices recorded under merged duplicate company entries are counted once.
Which registries list James Nguyen's devices?
Among its 1 most recently registered device, James Nguyen has devices listed in FDA 510(k) (1 device).
What risk classes do James Nguyen's devices fall under?
Among its 1 most recently registered device, the classes recorded for James Nguyen's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from James Nguyen in the registry?
The most recently registered devices listed for James Nguyen include WUNDER PREGNANCY TEST.