FDA Registration
Active
🇺🇸 United States
HCG Test kits
Reg #: 3038371011
·
FEI: 3038371011
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INNOTECH BIO CORPORATION
- Registration Number
- 3038371011
- FEI Number
- 3038371011
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 430 S CATARACT AVE FL 2ND
- City
- San Dimas
- State
- CA
- ZIP
- 91773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192843
Owner / Operator
- Firm Name
- Innotech Bio Corporation
- Operator Number
- 10093272
- Address
- 430 S CATARACT AVE FL 2ND
- City
- San Dimas
- State
- CA
- Postal Code
- 91773
- Country
- US
- Correspondent
- Fang Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-04-22 |
Proprietary Names
HCG Test kits
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)