FDA Registration
Active
🇺🇸 United States
Validate TDM1 product code 301db
Reg #: 1226774
·
FEI: 3003407015
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LGC Clinical Diagnostics, Inc.
- Registration Number
- 1226774
- FEI Number
- 3003407015
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 221 US Route 1
- City
- Cumberland Foreside
- State
- ME
- ZIP
- 04110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033879
Owner / Operator
- Firm Name
- LGC Clinical Diagnostics, Inc.
- Operator Number
- 9041170
- Address
- 37 Birch Street, --
- City
- Milford
- State
- MA
- Postal Code
- 01757
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2021-11-30 |
Proprietary Names
Validate TDM1 product code 301db
Validate TDM1 product code 301au
Validate TDM1 product code 301vt
Validate TDM1 product code 301bc
Validate TDM1 product code 301ri
VALIDATE TDM1 Calibration Verification Test Set
Validate TDM1 product code 301ab
Establishment Types
Manufacture Medical Device