ABBOTT DIABETES CARE INC.

FDA Device Registration & Listing · ALAMEDA, CA, US · Registration 2954323

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
2954323
FEI Number
3002803444
Entity Name
ABBOTT DIABETES CARE INC.
City/State/Country
ALAMEDA, CA, US
Establishment Address
1360 SOUTH LOOP RD., ALAMEDA, CA 94502, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
Y
Expiration Date (Year)
2026
510(k) Number
K202145
PMA Number
N/A

All Registered Proprietary Names

Precision Xtra Blood Glucose Test Strips FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System Instinct sensor Easy Touch Lancing Device FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System CoPilot Health Management System FreeStyle Freedom Lite Blood Glucose Monitoring System FreeStyle Lite Blood Glucose Monitoring System FreeStyle Precision Neo Blood Glucose Test Strips USB Data Cable Docking Station FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle InsuLinx Blood Glucose Monitoring System FreeStyle Blood Glucose Test Strips THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS FreeStyle Precision H Blood Glucose Monitoring System FreeStyle Lancet OPTIUM BLOOD B-KETONE TEST STRIPS PRECISION XTRA BLOOD B-KETONE TEST STRIPS ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) FreeStyle Libre Pro Software FreeStyle Libre Software LibreView Bigfoot Unity Report FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott SF Single Use Lancing Device FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Fiasp and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Fiasp and Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System - Cap for Fiasp Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Max Only Bigfoot Unity-Mobile App Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only Bigfoot Unity Program Kit Bigfoot Unity Diabetes Management System - Cap for Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Basaglar Only Bigfoot Unity Diabetes Management System - Cap for Novolog-Aspart Only Bigfoot Unity Diabetes Management System - Cap for Humalog-Lispro-Lyumjev Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Basaglar Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Basaglar Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Max Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Only Bigfoot Unity Diabetes Management System - Cap for Apidra/Admelog Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Fiasp and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Lantus -Glargine Only Bigfoot Unity Diabetes Management System - Cap for Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Levemir FlextTouch/Tresiba-Degludec Only

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
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
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2007-11-26
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
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 2007-11-26
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
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-10-12
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-12-07
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
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-06-28
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2010-06-28
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
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-11-29
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-11-29
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2007-11-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-11-22
PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry Class 1 862.2120 2017-12-07
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2014-02-03
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2014-02-03
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2014-02-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-02-03
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-11-29
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
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2024-06-25
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
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
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2021-05-10
QOG Injection Data Capture Device General Hospital Class 2 880.5860 2021-05-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
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
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-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-0044-2008 Becton Dickinson & Company 2
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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3003741676 ANDON HEALTH CO., LTD TIANJIN, CN
3004193489 NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS Billerica, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2954323. Last updated year: 2026. Please use registration number 2954323 when referencing this establishment in official correspondence.
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