Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006677029

FEI Number

3006677029

Entity Name

Beckman Coulter Biomedical GmbH

City/State/Country

Munchen Bavaria, DE

Establishment Address

Sauerbruchstr. 50, Munchen Bavaria 81377, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

DxA 5000 DxA 5000 Fit ODL25255 AutoMate 2550 LAB INSTRUMENT ODL25120 AutoMate 1200 LAB INSTRUMENT ODL25125 AutoMate 1250 LAB INSTRUMENT ODL25250 AutoMate 2500 LAB INSTRUMENT B36352 Power Express Sample Processing System B90918 Power Express Sample Processing System PLC AutoMate 2500 Sample Processing System AutoMate 1200 Sample Processing System AutoMate 2550 Sample Processing System AutoMate 1250 Sample Processing System ODL25250 AutoMate 2500 LAB INSTRUMENT ODL25255 AutoMate 2550 LAB INSTRUMENT A18894 Automate 800 Sample Processing System ODL25120 AutoMate 1200 LAB INSTRUMENT A18896 Automate 600 Sample Processing System ODL25125 AutoMate 1250 LAB INSTRUMENT Command Central Kaluza C Perpetual License (PN C10574) Kaluza C Flow Cytometry Software (PN C21166) Kaluza C Single Use 1 Year License (PN C10575) Kaluza C 10 User Network (PN C10576) DxOne Workflow Manager Kaluza C 5 User Network (PN C10577) REMISOL ADVANCE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2019-10-30
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2014-12-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-12-16
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2014-12-16
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2014-12-16
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2014-12-16
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2000-10-04

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
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN
3007750372	Beckman Coulter Distribution B.V.	Woerden Utrecht, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K830580	Iagnon Corp.	DIAGNON FERRITIN 125 I RIA KIT	1983-05-05
K100538	Roche Diagnostics	TINA-QUANT FERRITIN GEN. 4	2010-06-22
K172201	Siemens Healthcare Diagnostics, Inc.	Atellica IM Folate Assay	2018-04-12
K060755	Roche Diagnostics Corp.	ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK	2006-04-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006677029. Last updated year: 2026. Please use registration number 3006677029 when referencing this establishment in official correspondence.