FDA device listing
Phadia 1000,Phadia 250,Phadia 2500,Phadia 5000
FDA device listing 1556227634 · HITACHI HIGH-TECH CORP.
Key facts
| Proprietary names | Phadia 1000,Phadia 250,Phadia 2500,Phadia 5000 |
|---|---|
| Owner/operator | HITACHI HIGH-TECH CORP. |
| Owner/operator number | 9049564 |
| Product codes | DHB |
| Device names | DHB - System, Test, Radioallergosorbent (Rast) Immunological |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5750 |
| Review panels | Immunology |
| Registered establishments | HITACHI HIGH-TECH CORP., Musashimurayama Center, HITACHI HIGH-TECH CORP., Ome Works |
| Establishment registrations | 9610865, 3031570369 |
| FEI numbers | 3002806350, 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