FDA device listing
IWL2020 Blood Glucose Monitoring System,IWL2020 test strips,ReliOn Platinum
FDA device listing 1873962904 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | IWL2020 Blood Glucose Monitoring System,IWL2020 test strips,ReliOn Platinum |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K203711 |
| Product codes | NBW |
| Device names | NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIABETES CARE, INC. |
| Establishment registrations | 3011393376 |
| FEI numbers | 3011393376 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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