Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610942

FEI Number

3007262384

Entity Name

THERMO FISHER SCIENTIFIC OY

City/State/Country

VANTAA Uusimaa, FI

Establishment Address

2 RATASTIE, VANTAA Uusimaa 01620, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

THERMO FISHER SCIENTIFIC INC. (Owner Number: 2182773)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

U-TURN, Mek INTERNAL U-TURN PARALLEL BYPASS OLYMPUS AU680 RECAPPER 110 VAC 60 HZ Parallel Bypass TOSOH G8 TCA 800 INTERFACE FOR COBAS 8000 ALIQUOTER AND LABELLER LOADER, product no. 952312 Z-TURN, LEFT EXIT INTERFACE ImmunoCap 1000 CONVEYOR 1200 MM ENTRY Procleix Reagent Preparation Incubator RPI 250 (120V & 220-240V) CONVEYOR 2100 MM PARALLEL BYPASS LIAISON XL SYSMEX HST Interface DECAPPER FLEX INTERFACE ARCHITECT C8000 Z-TURN, RIGHT STAGO STA-R INTERFACE CONVEYOR 1800 MM PERPENDICULAR BYPASS, TCA for COLD STORAGE RACK LOADER, product no. 952292 T-TURN PARALLEL BYPASS TOSOH CENTRIFUGE MODULE PARALLEL BYPASS BECKMAN Unicel Dxl 800 ES Flex PARALLEL BYPASS FOR ACL Top STORAGE, product no. 952311 PARALLEL BYPASS VITROS 5.1 FS BUFFER CONVEYOR 900 MM CONVEYOR 2400 MM CONVEYOR 600 MM Propleix Reagent Preparation Incubator RPI (120V & 220-240V) CONVEYOR 1500 MM L-TURN LAS PC Win10 including SW TCA CONTROLLER PC Including SW Win10 INTERFACE ARCHITECT i2000SR PERPENDICULAR BYPASS VITROS 5.1 FS BULK INTERFACE MODULE CENTRIFUGE FLEX MODULE Tencell cuvette Optilite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2004-09-22
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2022-05-31
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2001-09-13

Official Correspondent

No official correspondent registered.

US Agent Details

Jonathan Abed Business: Senior Manager, Regulatory Affairs Email: jonathan.abed@thermofisher.com Phone: (541) 5884918

Related Public Records

Same Entity

THERMO FISHER SCIENTIFIC 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
3003809634	Thermo Finnigan LLC	San Jose, CA, US
1036832	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	ASHEVILLE, NC, US
8010672	THERMO ELECTRON LED GmbH	OSTERODE Lower Saxony, DE
1523845	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	MARIETTA, OH, US
9617472	THERMO ELECTRON LED GmbH	Langenselbold Hesse, DE

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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 9610942. Last updated year: 2026. Please use registration number 9610942 when referencing this establishment in official correspondence.