FDA device listing
IWL2020 Blood Glucose Monitoring System
FDA device listing 1211463086 · Altek Biotechnology Corporation
Key facts
| Proprietary names | IWL2020 Blood Glucose Monitoring System |
|---|---|
| Owner/operator | Altek Biotechnology Corporation |
| Owner/operator number | 10029462 |
| 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 | Altek Medical (kunshan) limited, Altek Medical Sdn. Bhd. |
| Establishment registrations | 3022346573, 3030311186 |
| FEI numbers | 3022346573, 3030311186 |
| 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