FDA Registration
Active
🇲🇽 Mexico
Clearblue Early Digital Pregnancy Test
Reg #: 3013160357
·
FEI: 3013160357
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RR Donnelley Global Turnkey Solutions
- Registration Number
- 3013160357
- FEI Number
- 3013160357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Blvd Internacional 881, San Jeronimo, CD
- City
- Juarez Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K200913
Owner / Operator
- Firm Name
- RR Donnelley Global Turnkey Solutions
- Operator Number
- 10052247
- Address
- 6315 W BY NORTHWEST BLVD
- City
- Houston
- State
- TX
- Postal Code
- 77040
- Country
- US
- Correspondent
- Lee Rush
US Agent
- Business Name
- RR Donnelley
- Contact Name
- Lee Rush
- Address
- 6315 North by Northwest Blvd., Houston
- City
- Houston
- State
- TX
- ZIP
- 77040
- Country
- US
- [email protected]
- Phone
- 979 4841734
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2022-07-07 |
Proprietary Names
Clearblue Early Digital Pregnancy Test
Clearblue Early & Digital Pregnancy Tests
Clearblue Triple Assurance Pregnancy Tests
Establishment Types
Repack or Relabel Medical Device