Mitsubishi Kagaku Iatron
Country not established
- Devices
- 4
What Mitsubishi Kagaku Iatron makes
Mitsubishi Kagaku Iatron manufactures rapid diagnostic tests for cardiac markers and coagulation factors, including PATHFAST N-terminal proBNP (NT-proBNP), D-dimer, high-sensitivity C-reactive protein (hsCRP), and cardiac enzymes such as CK-MB-II and Myoglobin (MYO-II). These tests are designed for point-of-care use to aid in the detection and monitoring of conditions like heart attack risk, inflammation, and venous thromboembolism.
The company’s diagnostic tests are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Pathfast Ntprobnp And D-Dimer Tests Ref K072189
Regimes: 510(k) Registry: 510(k)Pathfast D-Dimer Ref K072288
Regimes: 510(k) Registry: 510(k)Pathfast Hscrp Ref K083412
Regimes: 510(k) Registry: 510(k)Pathfast Ck-Mb-Ii, Pathfast Myo-Ii Ref K081360
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mitsubishi Kagaku Iatron have in the registry?
The registry currently lists 4 devices for Mitsubishi Kagaku Iatron. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitsubishi Kagaku Iatron's devices?
Among its 4 most recently registered devices, Mitsubishi Kagaku Iatron has devices listed in FDA 510(k) (4 devices).
What risk classes do Mitsubishi Kagaku Iatron's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Mitsubishi Kagaku Iatron's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mitsubishi Kagaku Iatron in the registry?
The most recently registered devices listed for Mitsubishi Kagaku Iatron include PATHFAST NTPROBNP AND D-DIMER TESTS, PATHFAST D-DIMER, PATHFAST HSCRP and PATHFAST CK-MB-II, PATHFAST MYO-II.