FDA Registration
Active
🇬🇧 United Kingdom
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Reg #: 9710492
·
FEI: 3003500908
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ABBOTT DIABETES CARE LIMITED
- Registration Number
- 9710492
- FEI Number
- 3003500908
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- RANGE RD.
- City
- WITNEY OXON Oxfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K132511
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 |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-02-03 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-02-03 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2014-02-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2014-02-03 |
Proprietary Names
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Establishment Types
Manufacture Medical Device