Mitsubishi Yuka America, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Mitsubishi Yuka America, Inc. makes
Mitsubishi Yuka America, Inc. manufactures diagnostic kits for hormone assays, including a calcitonin test kit and an ACTH (adrenocorticotropic hormone) immunoassay kit. These products are designed for laboratory use to measure specific hormone levels in patient samples.
The company’s diagnostic kits fall under FDA Class II devices and are listed via the 510(k) pathway. These products are regulated under U.S. medical device laws and appear in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Calcitonin Kit Mitsubishi Yuka Ref K912536
Regimes: 510(k) Registry: 510(k)Acth Irma Kit Ii Mitsubishi Yuka Ref K915727
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Yuka America, Inc. have in the registry?
The registry currently lists 2 devices for Mitsubishi Yuka America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Yuka America, Inc.'s devices?
Among its 2 most recently registered devices, Mitsubishi Yuka America, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mitsubishi Yuka America, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mitsubishi Yuka America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Yuka America, Inc. in the registry?
The most recently registered devices listed for Mitsubishi Yuka America, Inc. include CALCITONIN KIT MITSUBISHI YUKA and ACTH IRMA KIT II MITSUBISHI YUKA.