FDA Registration
Active
🇰🇷 South Korea
SmartBiopsy Isolation Kit
Reg #: 3006788232
·
FEI: 3006788232
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CYTOGEN, INC.
- Registration Number
- 3006788232
- FEI Number
- 3006788232
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- A-8F, SK V1 GL Metrocity, 128, Beobwon-ro, Songpa-gu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- CYTOGEN, Inc.
- Operator Number
- 10051266
- Address
- A-8F, SK V1 GL Metrocity, 128, Beobwon-ro, Songpa-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 05854
- Country
- KR
- Correspondent
- Byung Hee Jeon
US Agent
- Business Name
- ExperTox, Inc.
- Contact Name
- Ki Eun Kim
- Address
- 1430 Center St
- City
- Deer Park
- State
- TX
- ZIP
- 77536
- Country
- US
- [email protected]
- Phone
- 281 4764600
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Automated Blood Cell Diluting | GKH | Class 1 | Hematology | No | 2016-02-24 |
Proprietary Names
SmartBiopsy Isolation Kit
Smart Biopsy Cell Isolator - CIS030
Establishment Types
Manufacture Medical Device