FDA Registration
Active
🇺🇸 United States
Rika Plasma Separation Set
Reg #: 3017581284
·
FEI: 3017581284
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO BCT, INC.- Littleton
- Registration Number
- 3017581284
- FEI Number
- 3017581284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3525 Carder Ct
- City
- Highlands Ranch
- State
- CO
- ZIP
- 80129
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK210635
Owner / Operator
- Firm Name
- Terumo BCT, INC.
- Operator Number
- 9002708
- Address
- 10811 WEST COLLINS AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80215
- Country
- US
- Correspondent
- Corrine Lucas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2022-06-16 |
Proprietary Names
Rika Plasma Separation Set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)