Denka Seiken Co., Ltd.
JapanFDA applicant, unverified
- Devices
- 6
What Denka Seiken Co., Ltd. makes
Denka Seiken Co., Ltd. manufactures in vitro diagnostic (IVD) assay kits and reagents, including LDL cholesterol, HDL cholesterol, insulin, and C-reactive protein (CRP) measurement systems. The LDL-EX SEIKEN and HDL-EX SEIKEN kits quantify lipid profiles, while the CRP-LATEX (II)X2 SEIKEN kit and CRP (II) calibrators support inflammatory marker testing. The ARCHITECT Insulin and Controls system provides automated insulin level measurement for clinical use.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These assays are listed in the FDA’s 510(k) registry, reflecting their authorised status for in vitro diagnostic use in the United States.
Catalogue
s LDL-EX SEIKEN Ref K161679
Regimes: 510(k) Registry: 510(k)Ldl-Ex Seiken Assay Kit Ref K043264
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Crp-Latex (Ii)X2 Seiken Assay Kit Ref K030545
Regimes: 510(k) Registry: 510(k)Hdl-Ex Seiken Assay Kit Ref K041090
Regimes: 510(k) Registry: 510(k)Crp (Ii) Calibrators Ref K030546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Denka Seiken Co., Ltd. have in the registry?
The registry currently lists 6 devices for Denka Seiken Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denka Seiken Co., Ltd.'s devices?
Among its 6 most recently registered devices, Denka Seiken Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Denka Seiken Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Denka Seiken Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Denka Seiken Co., Ltd. in the registry?
The most recently registered devices listed for Denka Seiken Co., Ltd. include s LDL-EX SEIKEN, LDL-EX SEIKEN ASSAY KIT, ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 and CRP-LATEX (II)X2 SEIKEN ASSAY KIT.