Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005610352

FEI Number

3002806884

Entity Name

EIKEN CHEMICAL CO., LTD. NOGI PLANT

City/State/Country

SHIMOTSUGA-GUN Tochigi, JP

Establishment Address

143 NOGI, NOGI-MACHI,, SHIMOTSUGA-GUN Tochigi 329-0114, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EIKEN CHEMICAL CO., LTD. (Owner Number: 8031541)

Owner / Operator Contact Address

4-6 Kanda Surugadai, --, Chiyoda-ku, JP-13 101-0062, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041408

PMA Number

N/A

All Registered Proprietary Names

OC-Light S FIT OC-Auto Micro 80 FOB Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2015-09-14
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2008-01-09

Official Correspondent

Tadashi Yasuda

US Agent Details

Derek Wessman Business: Jataki Company LLC Email: Usagent@Jataki.com Phone: (801) 6569278

Related Public Records

Same Entity

EIKEN CHEMICAL CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007114058	Eiken Chemical Co., Ltd. Nasu Plant	Ohtawara-shi Tochigi, JP
9611917	EIKEN CHEMICAL CO., LTD.	Chiyoda-ku Tokyo, JP
3010392456	KT TAMASEIKI CO., LTD.	Hachiouji Tokyo, JP
3010391795	Nanbu Plastics Co., Ltd. Fujieda Factory	Fujieda-shi Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14

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3017231634	HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.	Hangzhou Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005610352. Last updated year: 2026. Please use registration number 3005610352 when referencing this establishment in official correspondence.