FDA Registration
Active
🇬🇧 United Kingdom
ABBOTT DIABETES CARE LIMITED
Reg #: 9710492
·
FEI: 3003500908
·
Expires 2026
Products
10
Proprietary Names
21
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- ABBOTT DIABETES CARE LIMITED
- Registration Number
- 9710492
- FEI Number
- 3003500908
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RANGE RD.
- City
- WITNEY OXON Oxfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K171941
- PMA Number
- P160030
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- Abbott Diabetes Care Inc.
- Contact Name
- Rodney Huang
- Address
- 1360 South Loop Road
- City
- Alameda
- State
- CA
- ZIP
- 94502
- Country
- US
- [email protected]
- Phone
- 510 2392614
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2017-10-12 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-09-14 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2009-01-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2009-01-19 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | Class 2 | Clinical Chemistry | No | 2020-06-16 |
| Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | PZE | Class 3 | Unknown | No | 2017-10-12 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2007-11-26 |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | Class 2 | Clinical Chemistry | No | 2024-06-25 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2016-09-26 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-02-03 |
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 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
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
Precision Xtra Blood Glucose Test Strips
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Establishment Types
Manufacture Medical Device