FDA Registration
Active
🇰🇷 South Korea
ADAMII-CD34 Kit
Reg #: 3009092698
·
FEI: 3009092698
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANOENTEK INC
- Registration Number
- 3009092698
- FEI Number
- 3009092698
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12F, 5, Digital-ro 26-gil, Guro-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- BK180283
Owner / Operator
- Firm Name
- NanoEntek, Inc
- Operator Number
- 10041714
- Address
- 220 Bear Hill Road Suite 102
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- NanoEntek America, Inc.
- Contact Name
- Jacob Jung
- Address
- 220 Bear Hill Road, Suite 102
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 781 4722558
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2019-10-09 |
Proprietary Names
ADAMII-CD34 Kit
ADAMII
ADAMII CD34 System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility