FDA device listing
LensHooke X12 PRO Semen Analysis System
FDA device listing 1481156719 · Hamilton Thorne, Inc.
Key facts
| Proprietary names | LensHooke X12 PRO Semen Analysis System |
|---|---|
| Owner/operator | Hamilton Thorne, Inc. |
| Owner/operator number | 1221433 |
| Product codes | OTQ |
| Device names | OTQ - Research Use Only/Hematology Devices |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.OTQ |
| Review panels | Hematology |
| Registered establishments | HAMILTON THORNE, Inc. |
| Establishment registrations | 1221433 |
| FEI numbers | 1221433 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database