Fujimori Kogyo, Co., Ltd.
JapanFDA 510(k) applicant, unverified
- Devices
- 1
What Fujimori Kogyo, Co., Ltd. makes
Fujimori Kogyo, Co., Ltd. manufactures the T-TAS 01 Total Thrombus-formation Analysis System, a medical device used for assessing thrombus formation in vitro. The system includes an instrument, disposable PL chips, chip reservoirs, and BAPA tubes designed for laboratory use in coagulation studies. These components work together to evaluate blood clotting dynamics under controlled conditions.
The company’s products fall under FDA Class II devices and are listed via the 510(k) pathway in the United States. The portfolio is regulated under US medical device regulations, ensuring compliance with pre-market notification requirements. The manufacturer operates from the United States.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does Fujimori Kogyo, Co., Ltd. have in the registry?
The registry currently lists 1 device for Fujimori Kogyo, Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fujimori Kogyo, Co., Ltd.'s devices?
Among its 1 most recently registered device, Fujimori Kogyo, Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Fujimori Kogyo, Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Fujimori Kogyo, Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fujimori Kogyo, Co., Ltd. in the registry?
The most recently registered devices listed for Fujimori Kogyo, Co., Ltd. include T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01.