Roche Diagnostics (Suzhou) Ltd.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3020917535

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3020917535
FEI Number
3020917535
Entity Name
Roche Diagnostics (Suzhou) Ltd.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
No.259 Zhongyuan Road, Suzhou Jiangsu 215028, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Roche Diagnostics Operations Inc. (Owner Number: 9039767)
Owner / Operator Contact Address
9115 Hague Road, Indianapolis, IN 46250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190773
PMA Number
N/A

All Registered Proprietary Names

Elecsys TSH TSH Elecsys E2G 300 V2 TSH Elecsys cobas e 200 V2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2019-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

Roche Diagnostics Operations 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
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB
3039322300 Roche Lumira Dx Bathgate Bathgate Scotland, GB
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
3011393376 ROCHE DIABETES CARE, INC. Indianapolis, IN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K850376 Terumo Medical Corp. TERUMO SENSIBEAD EIA TSH KIT 1985-03-04
K843395 Hybritech, Inc. ENCORE TSH REAGENT 1984-10-11
K854087 Organon Teknika Corp. NML TSH IRMA 1985-10-25
K151792 Siemens Healthcare Diagnostics, Inc. Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System 2015-11-20
K141999 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR TSH 2015-04-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2025 Qualigen Inc 2
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020 Roche Diagnostics Operations, Inc. 2
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Centaur XPT Immunoassay System

Similar Registrations

Registration Number Establishment Name Location
3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
1319808 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US
9680746 Beckman Coulter Ireland Inc O CALLAGHANS MILLS Clare, IE
2432235 Siemens Healthcare Diagnostics Inc. Tarrytown, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020917535. Last updated year: 2026. Please use registration number 3020917535 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.