Data / Medical devices / United Kingdom / Abbott Diabetes Care Limited

Abbott Diabetes Care Limited: FDA-registered device maker in WITNEY OXON Oxfordshire, United Kingdom, 18 510(k) clearances and 2 PMA approvals

Name: Abbott Diabetes Care Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Diabetes Care Limited is registered with the FDA (registration 9710492) in WITNEY OXON Oxfordshire, United Kingdom. It lists 10 device types. The FDA files 18 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 29, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9710492
FEI number: 3003500908
Address: Range RD., WITNEY OXON Oxfordshire, United Kingdom, OX29 0YL
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer
First device listed: November 26, 2007
Registered through: 2027
Brand names listed: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), FreeStyle Libre 3 Continuous Glucose Monitoring System, FreeStyle Libre Pro Flash Glucose Monitoring System, FreeStyle Precision H Blood Glucose Monitoring System, FreeStyle Precision Neo Blood Glucose Monitoring System and more

Devices it lists

Device	Product code	Class	Role	Source
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Manufacturer	accessdata.fda.gov
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	SAF	2	Manufacturer	accessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory Calibrated	QBJ	2	Manufacturer	accessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems	QLG	2	Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Manufacturer	accessdata.fda.gov
Sensor, Glucose, Invasive	MDS	3	Manufacturer	accessdata.fda.gov
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated	PZE	3	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 29, 2024	K233655	Lingo Glucose System	SAF	Substantially Equivalent	Abbott	accessdata.fda.gov
April 23, 2024	K233537	FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System	QBJ	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
April 13, 2023	K223435	FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System	QBJ	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
March 3, 2023	K222447	FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System	QBJ	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
May 26, 2022	K213996	FreeStyle Libre 3 Continuous Glucose Monitoring System	QLG	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
May 26, 2022	K212132	FreeStyle Libre 3 Continuous Glucose Monitoring System	QLG	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
November 22, 2021	K210943	FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)	QLG	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
July 30, 2021	K201761	FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)	QLG	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
June 12, 2020	K193371	FreeStyle Libre 2 Flash Glucose Monitoring System	QLG	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
September 27, 2017	K171941	FreeStyle Precision Neo Blood Glucose Test Strips	NBW	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
September 30, 2015	K142928	FreeStyle Precision Neo Blood Glucose Monitoring System	NBW	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
December 24, 2013	K132511	FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM	NBW	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
November 26, 2008	K081975	RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)	NBW	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
September 5, 2008	K080960	PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS	NBW	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
November 1, 2007	K070984	THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS	LFR	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
April 21, 2006	K060768	PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS	JIN	Substantially Equivalent	Abbott Diabetes Care, Inc.	accessdata.fda.gov
May 27, 2005	K051213	PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS	NBW	Substantially Equivalent	Abbott Laboratories, Inc.	accessdata.fda.gov
April 15, 2004	K040814	MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM	NBW	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 27, 2017	P160030	Freestyle Libre Flash Glucose Monitoring System	PZE	54	September 1, 2026	accessdata.fda.gov
September 23, 2016	P150021	FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM	MDS	59	September 1, 2026	accessdata.fda.gov

Compare with other makers

Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.