Mitsubishi Chemical Medience Corporation
United StatesFDA applicant, unverified
- Devices
- 3
What Mitsubishi Chemical Medience Corporation makes
Mitsubishi Chemical Medience Corporation manufactures in vitro diagnostic reagents, including calibrators and sample diluents for cardiac troponin I (CTNI), cardiac troponin light chain (CTNL), and creatine kinase-MB (CK-MB) assays. These products support quantitative analysis in clinical laboratories for detecting and monitoring cardiac conditions.
The company’s portfolio is regulated as Class II medical devices under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Pathfast Ctnl Calibrators Ref K130603
Regimes: 510(k) Registry: 510(k)Pathfast Ck-Mb-Ii Calibrators Ref K130628
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Chemical Medience Corporation have in the registry?
The registry currently lists 3 devices for Mitsubishi Chemical Medience Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Chemical Medience Corporation's devices?
Among its 3 most recently registered devices, Mitsubishi Chemical Medience Corporation has devices listed in FDA 510(k) (3 devices).
What risk classes do Mitsubishi Chemical Medience Corporation's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mitsubishi Chemical Medience Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Chemical Medience Corporation in the registry?
The most recently registered devices listed for Mitsubishi Chemical Medience Corporation include PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2, PATHFAST CTNL CALIBRATORS and PATHFAST CK-MB-II CALIBRATORS.