FDA Registration
Active
🇺🇸 United States
Body Fluid Control
Reg #: 1017835
·
FEI: 1017835
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 1017835
- FEI Number
- 1017835
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 740 WEST 83RD ST.
- City
- HIALEAH
- State
- FL
- ZIP
- 33014
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082162
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2012-09-11 |
Proprietary Names
Body Fluid Control
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)