Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612296

FEI Number

3002807663

Entity Name

Beckman Coulter Mishima K.K.

City/State/Country

SUNTO-GUN Shizuoka, JP

Establishment Address

454-32 HIGASHINO,NAGAIZUMI-CHO, SUNTO-GUN Shizuoka 411-0931, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B86444 DxC 700 AU with ISE B86446 DxC 700 AU for Direct Track Sampling with ISE B86445 DxC 700 AU for Direct Track Sampling B86443 DxC 700 AU AU Beckman Coulter Chemistry Analyzers Beckman Coulter Chemistry Analyzer AU480 DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter Chemistry Analyzer AU5800 Beckman Coulter Chemistry Analyzer AU680 DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522 (JPN MFG) DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63521 (JPN MFG) DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, C13252 (Chaska MFG)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2016-12-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-12-20
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2016-12-20
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-12-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-08-13
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-08-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2011-12-29
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-07-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-03-07
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Ian Pilcher Business: Beckman Coulter, Inc. Email: ipilcher@beckman.com Phone: (443) 3506459

Related Public Records

Same Entity

BECKMAN COULTER, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
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 9612296. Last updated year: 2026. Please use registration number 9612296 when referencing this establishment in official correspondence.