Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003637681

FEI Number

3003637681

Entity Name

JEOL LTD.

City/State/Country

Musashimurayama Tokyo, JP

Establishment Address

2-11-1 Inadaira, Musashimurayama Tokyo 208-0023, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JEOL LTD. (Owner Number: 9051046)

Owner / Operator Contact Address

2-11-1 Inadaira, --, Musashimrayama, JP-13 208-0023, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sodium Electrode Chloride Electrode Potassium Electrode Reagent Probe Wash K Cuvette Conditioner EX Reagent Probe Wash 1 ISE Buffer (IS) Reagent Probe Wash S Cuvette Wash Solution 7 Reagent Probe Wash 2 Lamp Coolant C ISE Detergent Solution Cuvette Wash Solution 3 BM Test BATH FLUID 50 Cuvette Conditioner 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-07-09
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-07-09
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-07-09
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-07-09
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2021-11-09

Official Correspondent

Takeshi Kaneko

US Agent Details

Yoshiki Yamasaki Email: yyamasaki@jeol.com Phone: (978) 4952105

Related Public Records

Same Entity

JEOL LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

Similar Registrations

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
9612296	Beckman Coulter Mishima K.K.	SUNTO-GUN Shizuoka, JP
3006198300	Diamond Diagnostics Inc.	Budapest, HU
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003637681. Last updated year: 2026. Please use registration number 3003637681 when referencing this establishment in official correspondence.