Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004438098

FEI Number

3004438098

Entity Name

FURUNO ELECTRIC CO., LTD.

City/State/Country

NISHINOMIYA-CITY Hyogo, JP

Establishment Address

2-20, Nishinomiyahama, NISHINOMIYA-CITY Hyogo 662-0934, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Furuno Electric Co., Ltd. (Owner Number: 9048176)

Owner / Operator Contact Address

9-52 Ashihara-Cho, Nishinomiya-City, JP-28 662-8580, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090703

PMA Number

N/A

All Registered Proprietary Names

RX Imola RX Daytona Poly-Chem Poly-Chem 90

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	2013-01-31
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-01-31
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-01-31
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-01-31
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-01-31
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-01-31
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2013-01-31
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-01-31
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-01-31
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-01-31
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-01-31
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-04-10
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2012-04-10
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2012-04-10
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

Bradley Reents Business: Furuno U.S.A., Inc. Email: breents@furuno.com Phone: (360) 8349300

Related Public Records

Same Entity

Furuno Electric Co., 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
K881300	Medical Analysis Systems, Inc.	MAGNESIUM LIQUID STABLE REAGENT SET	1988-05-17
K162399	Siemens Healthcare Diagnostics, Inc.	Atellica CH Magnesium (Mg)	2017-01-19

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004438098. Last updated year: 2026. Please use registration number 3004438098 when referencing this establishment in official correspondence.