Seju Engineering Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Seju Engineering Co., Ltd. makes
Seju Engineering Co., Ltd. manufactures personal alcohol detection devices, including breath alcohol test systems designed for individual use.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seju Engineering Co., Ltd. have in the registry?
The registry currently lists 1 device for Seju Engineering Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seju Engineering Co., Ltd.'s devices?
Among its 1 most recently registered device, Seju Engineering Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Seju Engineering Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Seju Engineering Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Seju Engineering Co., Ltd. in the registry?
The most recently registered devices listed for Seju Engineering Co., Ltd. include PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM.