FDA Registration
Active
🇺🇸 United States
Cholestech LDX TC
Reg #: 2027969
·
FEI: 1000125596
·
Expires 2025
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Alere San Diego, Inc.
- Registration Number
- 2027969
- FEI Number
- 1000125596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9942 Mesa Rim Road
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223179
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2023-12-18 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2023-12-18 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-12-18 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-12-18 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-12-18 |
Proprietary Names
Cholestech LDX TC
Cholestech LDX TC HDL GLU
Cholestech LDX Lipid Profile
Cholestech LDX TC/HDL
Cholestech LDX Lipid Profile GLU
Cholestech LDX TC GLU
Establishment Types
Manufacture Medical Device