Data / Medical devices / Japan / Eiken Chemical Co., Ltd.
Eiken Chemical Co., Ltd.: FDA-registered device maker in Chiyoda-ku Tokyo, Japan, 4 510(k) clearances
Eiken Chemical Co., Ltd. is registered with the FDA (registration 9611917) in Chiyoda-ku Tokyo, Japan. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611917
- FEI number
- 3009431614
- Address
- 4-6 Kanda Surugadai, Chiyoda-ku Tokyo, Japan, 101-0062
- Owner or operator
- EIKEN CHEMICAL CO., LTD. (8031541)
- Roles
- Specification developer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- OC-Auto Micro 80 FOB Test, OC-Auto Sensor io iFOB Test, OC-Light S FIT, OC-Sensor DIANA iFOB Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Occult Blood Analyzer | OOX | 2 | Specification developer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 2, 2020 | K191147 | OC-Auto SENSOR io iFOB Test | OOX | Substantially Equivalent | Eiken Chemical Co., Ltd. | accessdata.fda.gov |
| August 20, 2015 | K143325 | OC-Light S FIT | KHE | Substantially Equivalent | Eiken Chemical Co., Ltd. | accessdata.fda.gov |
| January 8, 2010 | K092330 | OC-SENSOR DIANA IFOB TEST | OOX | Substantially Equivalent | Polymedco Cancer Diagnostics, LLC | accessdata.fda.gov |
| October 21, 2004 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.