Denka Seiken'S
JapanFDA applicant, unverified
- Devices
- 4
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Mrsa-Screen Ref K011400
Regimes: 510(k) Registry: 510(k)LP(A)-Latex Seiken Assay Kit Ref K013359
Regimes: 510(k) Registry: 510(k)Vtec-Rpla Seiken Ref K981734
Regimes: 510(k) Registry: 510(k)Crp-Latex (Ii) Seiken High Sensitivity Assay Kit Ref K011958
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Denka Seiken'S have in the registry?
The registry currently lists 4 devices for Denka Seiken'S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denka Seiken'S's devices?
Among its 4 most recently registered devices, Denka Seiken'S has devices listed in FDA 510(k) (4 devices).
What risk classes do Denka Seiken'S's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Denka Seiken'S'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'S in the registry?
The most recently registered devices listed for Denka Seiken'S include MRSA-SCREEN, LP(A)-LATEX SEIKEN ASSAY KIT, VTEC-RPLA SEIKEN and CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT.