FDA Registration
Active
🇺🇸 United States
EsoCheck CCD-Lucid Diagnostics
Reg #: 3013944123
·
FEI: 3013944123
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Eurofins Infinity Laboratory Group Inc.
- Registration Number
- 3013944123
- FEI Number
- 3013944123
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1836 Stone Ave
- City
- San Jose
- State
- CA
- ZIP
- 95125
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183262
Owner / Operator
- Firm Name
- Eurofins - Infinity Laboratory Group Inc.
- Operator Number
- 10080298
- Address
- 1836 Stone Ave
- City
- San Jose
- State
- CA
- Postal Code
- 95125
- Country
- US
- Correspondent
- Jennifer Eagan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2021-01-25 |
Proprietary Names
EsoCheck CCD-Lucid Diagnostics
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)