FDA Registration
Active
🇺🇸 United States
CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33)
Reg #: 3016438761
·
FEI: 3016438761
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
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
- K083809
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2022-01-06 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2016-03-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2022-01-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-01-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-01-06 |
Proprietary Names
CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33)
Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility