FDA Registration
Active
🇮🇪 Ireland
Access Intact PTH (P/N: A16972 MN and IE MFG)
Reg #: 9680746
·
FEI: 1000206808
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Beckman Coulter Ireland Inc
- Registration Number
- 9680746
- FEI Number
- 1000206808
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LISMEEHAN
- City
- O CALLAGHANS MILLS Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K232791
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2024-03-07 |
Proprietary Names
Access Intact PTH (P/N: A16972 MN and IE MFG)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)