FDA device listing
Add-On Buffer Unit,CCM Address Extension Unit,CCM Backend Connection Unit,CCM Bidirectional Interface,CCM cobas c513…
FDA device listing 1107527317 · HITACHI HIGH-TECH CORP.
Key facts
| Proprietary names | Add-On Buffer Unit,CCM Address Extension Unit,CCM Backend Connection Unit,CCM Bidirectional Interface,CCM cobas c513 Connection Unit,CCM Vertical Elevator Unit,CCM Vertical Overhead Conveyor Unit (1.0m),CCM Vertical Power Box Unit,CCM Vertical Turntable Unit,Cobas 6000 Connection Unit,Cobas 8000 Connection Unit,cobas 8100 automated workflow series,CONVEYOR 1 Unit,CONVEYOR 2 Unit,CONVEYOR 3… |
|---|---|
| Owner/operator | HITACHI HIGH-TECH CORP. |
| Owner/operator number | 9049564 |
| Product codes | JQP |
| Device names | JQP - Calculator/Data Processing Module, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2100 |
| Review panels | Clinical Chemistry |
| Registered establishments | HITACHI HIGH-TECH CORP., Musashimurayama Center, HITACHI HIGH-TECH CORP., NAKA DIVISION, HITACHI HIGH-TECH CORP., Ome Works, Hitachi High-Tech Corp., Omuta Center |
| Establishment registrations | 9610865, 9614673, 3014840402, 3031570369 |
| FEI numbers | 3002806350, 3003559576, 3014840402, 3031570369 |
| 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