Koreamedico Co., Ltd.
South KoreaFDA 510(k) applicant, unverified
- Devices
- 1
What Koreamedico Co., Ltd. makes
Koreamedico Co., Ltd. manufactures the KoreaMedico Chextic HCG Urine Pregnancy Test, a lateral flow immunoassay device designed for detecting human chorionic gonadotropin (hCG) in urine to confirm pregnancy.
The device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Koreamedico Chextic Hcg Urine Pregnancy Test Ref K062096
510(k) 510(k)
Frequently asked questions
How many devices does Koreamedico Co., Ltd. have in the registry?
The registry currently lists 1 device for Koreamedico Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koreamedico Co., Ltd.'s devices?
Among its 1 most recently registered device, Koreamedico Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Koreamedico Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Koreamedico Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koreamedico Co., Ltd. in the registry?
The most recently registered devices listed for Koreamedico Co., Ltd. include KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST.