ABBOTT DIABETES CARE LIMITED

FDA Device Registration & Listing · WITNEY OXON Oxfordshire, GB · Registration 9710492

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
9710492
FEI Number
3003500908
Entity Name
ABBOTT DIABETES CARE LIMITED
City/State/Country
WITNEY OXON Oxfordshire, GB
Establishment Address
RANGE RD., WITNEY OXON Oxfordshire OX29 0YL, GB
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
N
Expiration Date (Year)
2026
510(k) Number
K142928
PMA Number
N/A

All Registered Proprietary Names

FreeStyle Precision Neo Blood Glucose Test Strips FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System Relion Ultima Advance Blood Glucose OptiumEZ Blood Glucose Monitoring S FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 14 day Flash Glucose Monitoring System Precision Xtra Advanced Diabetes Ma Precision Xtra Blood Glucose and Ketone Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) OPTIUM BLOOD B-KETONE TEST STRIPS PRECISION XTRA BLOOD B-KETONE TEST STRIPS FreeStyle Libre Pro Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System Instinct sensor THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS FreeStyle Precision H Blood Glucose Monitoring System Precision Xceed Pro Blood Glucose and Ketone Monitoring System Precision PCx Plus Blood Glucose Test Strips Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips FreeStyle Precision Neo Blood Glucose Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-10-12
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2023-09-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-09-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-01-19
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2009-01-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-01-19
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2020-06-16
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-06-16
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2022-05-26
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2022-05-26
PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown Class 3 N/A 2017-10-12
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2007-11-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2007-11-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-11-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-11-22
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2021-11-22
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2007-11-26
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2024-06-25
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2016-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-06-30
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2023-06-30
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2021-07-31
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-07-31
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-12-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2024-12-09
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2024-12-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-11-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2007-11-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2008-09-11
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2008-09-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2008-09-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Rodney Huang Business: Abbott Diabetes Care Inc. Email: rodney.huang@abbott.com Phone: (510) 2392614

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
3004032053 Abbott S.r.l. Milan Lombardy, IT
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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number Establishment Name Location
3005706626 Bioptik Technology, Inc. Jhunan Township Miaoli, TW
3004539335 CONDUCTIVE TECHNOLOGIES, INC. York, PA, US
3014302067 MICROTECH MEDICAL (HANGZHOU) CO., LTD. Hangzhou Zhejiang, CN
3014353121 VIDAN DIAGNOSTICS, LLC San Antonio, TX, 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 9710492. Last updated year: 2026. Please use registration number 9710492 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.