FDA Registration
Active
🇺🇸 United States
Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930)
Reg #: 3005333358
·
FEI: 3005333358
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3005333358
- FEI Number
- 3005333358
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Conway Park, 675 North Field Drive
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181748
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 |
|---|---|---|---|---|---|
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2018-12-18 |
Proprietary Names
Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930)
Magnesium (LN 3P68-22, 3P68-32)
Magnesium (Alinity c; LN 08P1925, 08P1934)
Magnesium (ARCHITECT; LN 03P6824, 03P6834)
Establishment Types
Complaint File Establishment per 21 CFR 820.198