FDA Registration
Active
🇨🇳 China
Atlas One Step hCG Urine Pregnancy Test
Reg #: 3016849811
·
FEI: 3016849811
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Atlas Link Technology Co., Ltd.
- Registration Number
- 3016849811
- FEI Number
- 3016849811
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Xing Min Road, South Industrial Park
- City
- Langfang Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203246
Owner / Operator
- Firm Name
- Atlas Link Inc.
- Operator Number
- 10069679
- Address
- 10758-A Ambassador Drive
- City
- Manassas
- State
- VA
- Postal Code
- 20109
- Country
- US
- Correspondent
- Zhun Shi
US Agent
- Business Name
- Atlas Link Inc
- Contact Name
- Hamed Tadayon Tadayon
- Address
- 10758 A Ambassador Drive
- City
- Manassas
- State
- VA
- ZIP
- 20109
- Country
- US
- [email protected]
- Phone
- 703 3663851
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-02-21 |
Proprietary Names
Atlas One Step hCG Urine Pregnancy Test
Establishment Types
Manufacture Medical Device