Data / Medical devices / Japan / Eiken Chemical Co., Ltd. Nogi Plant
Eiken Chemical Co., Ltd. Nogi Plant: FDA-registered device maker in SHIMOTSUGA-GUN Tochigi, Japan, 4 510(k) clearances
Eiken Chemical Co., Ltd. Nogi Plant is registered with the FDA (registration 3005610352) in SHIMOTSUGA-GUN Tochigi, 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
- 3005610352
- FEI number
- 3002806884
- Address
- 143 Nogi Nogi-Machi, SHIMOTSUGA-GUN Tochigi, Japan, 329-0114
- Owner or operator
- EIKEN CHEMICAL CO., LTD. (8031541)
- Roles
- Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Manufacturer | 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.