FDA Registration
Active
🇨🇿 Czechia
Ultra-sensitive Estradiol RIA
Reg #: 3003385757
·
FEI: 3003385757
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMMUNOTECH s.r.o.
- Registration Number
- 3003385757
- FEI Number
- 3003385757
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Radiova 1
- City
- Prague Praha, Hlavni Mesto
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K953605
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- David G Davis
US Agent
- Business Name
- BECKMAN COULTER, INC.
- Contact Name
- David Davis
- Address
- 250 S. Kraemer Blvd.
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 469 2368180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2017-12-07 |
Proprietary Names
Ultra-sensitive Estradiol RIA
Establishment Types
Manufacture Medical Device