FDA Registration
Active
🇺🇸 United States
Alinity c System
Reg #: 3016438761
·
FEI: 3016438761
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3016438761
- FEI Number
- 3016438761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1915 Hurd Drive
- City
- Irving
- State
- TX
- ZIP
- 75038
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230790
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-06-05 |
Proprietary Names
Alinity c System
Alinity i System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device