Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004032053

FEI Number

3004032053

Entity Name

Abbott S.r.l.

City/State/Country

Milan Lombardy, IT

Establishment Address

Viale Thomas Alva Edison, 110, Sesto San Giovanni, Milan Lombardy 20099, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AlinIQ AMS (LN 03R89-21, 03R89-23, 03R89-24, 03R89-47, 03R89-48, 03R89-59, 03R89-62, 03R89-63, 03R89-65, 03R89-67)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	1999-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Sara Qadri Business: ABBOTT LABORATORIES Email: sara.qadri@abbott.com Phone: (224) 6680142

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR
3038966633	Abbott Medical Mexico, S. de R.L. de C.V.	Santa Rosa Jauregui Queretaro, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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3012436569	NATIONAL TECHNOLOGY FOR SOFTWARE	Cairo Al Qahirah, EG
3015426626	Aclarion, Inc.	Broomfield, CO, US
3030413550	LIFE DATA LAB, LLC	New York, NY, US
3008514395	Telcare, LLC	Linwood, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004032053. Last updated year: 2026. Please use registration number 3004032053 when referencing this establishment in official correspondence.