Wako Pure Chemical Industries, Ltd.
Country not established
- Devices
- 6
What Wako Pure Chemical Industries, Ltd. makes
Wako Pure Chemical Industries, Ltd. manufactures diagnostic reagents for laboratory testing, including kits for measuring ammonia levels, triglycerides, phospholipids, HDL cholesterol, and glucose in blood samples. These products are designed for clinical chemistry applications, supporting quantitative analysis in medical diagnostics.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These reagents are intended for use in the United States and are listed in the FDA’s 510(k) database. The company is based in the US.
Catalogue
Ammonia Test Ref K813366
Regimes: 510(k) Registry: 510(k)Wako Triglyceride-G Test Ref K801891
Regimes: 510(k) Registry: 510(k)Wako Phospholipids Test Ref K801076
Regimes: 510(k) Registry: 510(k)Wako Triglyceride Ref K791597
Regimes: 510(k) Registry: 510(k)Wako Hdl Cholesterol Test Ref K801834
Regimes: 510(k) Registry: 510(k)Wako Glucose C Ref K842221
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wako Pure Chemical Industries, Ltd. have in the registry?
The registry currently lists 6 devices for Wako Pure Chemical Industries, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wako Pure Chemical Industries, Ltd.'s devices?
Among its 6 most recently registered devices, Wako Pure Chemical Industries, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Wako Pure Chemical Industries, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Wako Pure Chemical Industries, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wako Pure Chemical Industries, Ltd. in the registry?
The most recently registered devices listed for Wako Pure Chemical Industries, Ltd. include AMMONIA TEST, WAKO TRIGLYCERIDE-G TEST, WAKO PHOSPHOLIPIDS TEST and WAKO TRIGLYCERIDE.