FDA Registration
Active
🇺🇸 United States
ACCUNATE HOME PREGNANCY TEST
Reg #: 2250030
·
FEI: 2250030
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CENOGENICS CORP.
- Registration Number
- 2250030
- FEI Number
- 2250030
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 RT. 520, Drawer 308
- City
- MORGANVILLE
- State
- NJ
- ZIP
- 07751
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030533
Owner / Operator
- Firm Name
- CENOGENICS CORPORATION
- Operator Number
- 2243923
- Address
- 100 RT. 520
- City
- Morganville
- State
- NJ
- Postal Code
- 07751
- Country
- US
- Correspondent
- NITZA KATZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2006-05-16 |
Proprietary Names
ACCUNATE HOME PREGNANCY TEST
Establishment Types
Repack or Relabel Medical Device