FDA Registration
Active
🇨🇳 China
CLARITY hCG Combo Cassette
Reg #: 3012073813
·
FEI: 3012073813
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Hangzhou AllTest Biotech Co.,Ltd
- Registration Number
- 3012073813
- FEI Number
- 3012073813
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203272
Owner / Operator
- Firm Name
- Hangzhou AllTest Biotech Co.,Ltd
- Operator Number
- 10050156
- Address
- No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
- Correspondent
- Yanli Wu
US Agent
- Business Name
- ACESO LABORATORIES INC.
- Contact Name
- Joseph Fan
- Address
- 14020 Central Ave, Suite 520
- City
- Chino
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 310 8060719
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2022-02-18 |
Proprietary Names
CLARITY hCG Combo Cassette
CHOSEN hCG Pregnancy Combo Rapid Test Cassette Rx
ACRO hCG Pregnancy Combo Test
Alltest Pregnancy Rapid Combo Test Cassette
Atida hCG Pregnancy Rapid Combo Test
Medline hCG Combo Pregnancy Test Cassette
Citest hCG Pregnancy Combo Rapid Test
Establishment Types
Manufacture Medical Device