FDA Registration
Active
🇺🇸 United States
LensHooke X1 PRO SE Semen Quality Analyzer
Reg #: 1221433
·
FEI: 1221433
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HAMILTON THORNE, Inc.
- Registration Number
- 1221433
- FEI Number
- 1221433
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 100 CUMMINGS CENTER-SUITE 465E
- City
- Beverly
- State
- MA
- ZIP
- 01915
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202089
Owner / Operator
- Firm Name
- Hamilton Thorne, Inc.
- Operator Number
- 1221433
- Address
- 100 Cummings Center, Suite 465E
- City
- Beverly
- State
- MA
- Postal Code
- 01915
- Country
- US
- Correspondent
- Nicole M Thibodeau
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2021-08-24 |
Proprietary Names
LensHooke X1 PRO SE Semen Quality Analyzer
Establishment Types
Complaint File Establishment per 21 CFR 820.198