Eiken Chemical Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Eiken Chemical Co., Inc. makes
Eiken Chemical Co., Inc. manufactures multipurpose immunochemistry systems, including the Sys-LA-2000 and its latex variant, designed for laboratory-based diagnostic testing. These systems support automated detection and analysis of antigens or antibodies in clinical samples, aiding in infectious disease and allergy diagnostics.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are listed in the US market, adhering to FDA requirements for medical devices.
Catalogue
Multipurpose Immunochemistry Sys-La-2000 Ref K853391
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eiken Chemical Co., Inc. have in the registry?
The registry currently lists 2 devices for Eiken Chemical Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eiken Chemical Co., Inc.'s devices?
Among its 2 most recently registered devices, Eiken Chemical Co., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Eiken Chemical Co., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eiken Chemical Co., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eiken Chemical Co., Inc. in the registry?
The most recently registered devices listed for Eiken Chemical Co., Inc. include MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 and MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX.