Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611917

FEI Number

3009431614

Entity Name

EIKEN CHEMICAL CO., LTD.

City/State/Country

Chiyoda-ku Tokyo, JP

Establishment Address

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

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K143325

PMA Number

N/A

All Registered Proprietary Names

OC-Auto Micro 80 FOB Test OC-Auto Sensor io iFOB Test OC-Sensor DIANA iFOB Test OC-Light S FIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2008-01-09
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2020-01-05
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2010-02-05
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2015-09-14

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
3010392456	KT TAMASEIKI CO., LTD.	Hachiouji Tokyo, JP
3010391795	Nanbu Plastics Co., Ltd. Fujieda Factory	Fujieda-shi Shizuoka, JP
3005610352	EIKEN CHEMICAL CO., LTD. NOGI PLANT	SHIMOTSUGA-GUN Tochigi, 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

Similar Registrations

Registration Number	Establishment Name	Location
3007114058	Eiken Chemical Co., Ltd. Nasu Plant	Ohtawara-shi Tochigi, JP
3030896267	WellPact	Roaring Spring, PA, US
2435505	POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.	CORTLANDT MANOR, NY, US
9610865	HITACHI HIGH-TECH CORP., Ome Works	Ome-Shi Tokyo, JP
3017923561	SARIS AND THINGS, INC.	Plainfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611917. Last updated year: 2026. Please use registration number 9611917 when referencing this establishment in official correspondence.