FDA device listing
944-519 S7620 QUALICHECK 7+, level 0,944-520 S7630 QUALICHECK 7+, level 1,944-521 S7640 QUALICHECK 7+, level 2,944-522…
FDA device listing 1594106069 · Radiometer Medical ApS
Key facts
| Proprietary names | 944-519 S7620 QUALICHECK 7+, level 0,944-520 S7630 QUALICHECK 7+, level 1,944-521 S7640 QUALICHECK 7+, level 2,944-522 S7650 QUALICHECK 7+, level 3,944-523 S7660 QUALICHECK 7+, level 4 |
|---|---|
| Owner/operator | Radiometer Medical ApS |
| Owner/operator number | 9064213 |
| Product codes | JJY |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | RADIOMETER MEDICAL APS |
| Establishment registrations | 3002807968 |
| FEI numbers | 3002807968 |
| Establishment operations | 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