FDA device listing
Clinical Laboratory Automation System (CLAS),Dummy HPLC Cartridge,Dummy Rapid Cartridge
FDA device listing 1591483720 · HITACHI HIGH-TECH CORP.
Key facts
| Proprietary names | Clinical Laboratory Automation System (CLAS),Dummy HPLC Cartridge,Dummy Rapid Cartridge |
|---|---|
| Owner/operator | HITACHI HIGH-TECH CORP. |
| Owner/operator number | 9049564 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | HITACHI HIGH-TECH CORP., NAKA DIVISION, Hitachi High-Tech Corp., Omuta Center |
| Establishment registrations | 9614673, 3014840402 |
| FEI numbers | 3003559576, 3014840402 |
| Establishment operations | Contract Manufacturer |
| 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