Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027977508

FEI Number

3027977508

Entity Name

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.11, Zhensheng Road, Suzhou Industrial Park, Area 1, 1st Floor, Building 4; Area 1, Building 3; Area 1, Building 2, Suzhou Jiangsu 215126, CN

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

Access C-Peptide (P/N: C33451) Access Sensitive Estradiol Calibrator S0 (P/N: B97145) Access Sensitive Estradiol Calibrators (P/N: B84494) Access C-Peptide Calibrators (P/N: C31860) Access Syphilis Calibrators (P/N: C80412 MFG-BioRad) DxC 500 AU Clinical Chemistry Analyzer A15445 IMMAGE 800

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	1999-04-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-02-02
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	2013-02-08
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	Class 1	862.2700	2013-02-08

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
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Similar Registrations

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3009984016	GETEIN BIOTECH, INC.	Nanjing Jiangsu, CN
9612316	TOSOH AIA, INC.	TOYAMA, JP
3003741796	DIRUI INDUSTRIAL CO., LTD.	CHANGCHUN Jilin, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027977508. Last updated year: 2026. Please use registration number 3027977508 when referencing this establishment in official correspondence.