FDA Registration
Active
🇰🇷 South Korea
DAGATRON DX-300
Reg #: 3009596884
·
FEI: 3009596884
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DAGATRONICS CORPORATION
- Registration Number
- 3009596884
- FEI Number
- 3009596884
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 117, Tanjung-ro, Ilsanseo-gu
- City
- Goyang Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- DAGATRONICS CORPORATION
- Operator Number
- 10049067
- Address
- 117, Tanjung-ro, Ilsanseo-gu
- City
- Goyang
- State
- Gyeonggi
- Postal Code
- 10233
- Country
- KR
US Agent
- Business Name
- J.S. CHEM INTERNATIONAL CO.
- Contact Name
- Grace Kim
- Address
- 20155 Pingree Way
- City
- Yorba Linda
- State
- CA
- ZIP
- 92887
- Country
- US
- [email protected]
- Phone
- 310 5983012
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2015-04-08 |
Proprietary Names
DAGATRON DX-300
AT-3002 GRAM/AFB(Z/N) Dual Stainer
AT-2000F Fluorescence AFB Auto Stainer
AT-3003 GRAM/AFB(F/L) Dual Stainer
AT-2000G GRAM Auto Stainer
AT-3001 AFB Multi Stainer
AT-3004 GRAM/HEMA(MGG) Dual Stainer
AT-2000H HEMA(MGG or WR) Auto Stainer
AT-2000Z Ziehl-Neelsen AFB Auto Stainer
AT-2000K Kinyoun AFB Auto Stainer
Establishment Types
Manufacture Medical Device