Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000256526

FEI Number

1000256526

Entity Name

HORIBA LTD.

City/State/Country

KYOTO, JP

Establishment Address

2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU, KYOTO 601-8510, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HORIBA LTD. (Owner Number: 9052537)

Owner / Operator Contact Address

2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU, KYOTO, JP-26 601-8510, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sodium Electrode Potassium Electrode YUMIZEN C1200 Chloride Electrode Reagent Probe Wash 2 ISE Detergent Solution Reagent Probe Wash K Reagent Probe Wash 1 Cuvette Wash Solution 7 Cuvette Conditioner EX Lamp Coolant C ISE Buffer (IS) Reagent Probe Wash S I.S.E.MODULE ISE URINE STANDARD SET Internal Standard ISE SERUM STANDARD SET NA

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	2019-12-25
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-12-25
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2019-12-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2019-12-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2019-12-25
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2002-11-07
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-02-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-02-01
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-02-01
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-02-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2020-11-30

Official Correspondent

JUNYA OKETANI

US Agent Details

Will Cripps Business: HORIBA Instruments Incorporated Email: william.cripps@horiba.com Phone: (800) 4459853

Related Public Records

Same Entity

HORIBA 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
K761345	J.T. Baker Chemical Co.	GLUCO-HEX TM REAGENT KIT	1977-01-05
K771464	Instrumentation Laboratory CO	MULTISTAT III GLUCOSE TEST	1977-09-02
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10

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-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000256526. Last updated year: 2026. Please use registration number 1000256526 when referencing this establishment in official correspondence.