FDA device listing
FreeStyle Libre 2 Flash Glucose Monitoring System
FDA device listing 1820507570 · ABBOTT LABORATORIES
Key facts
| Proprietary names | FreeStyle Libre 2 Flash Glucose Monitoring System |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K193371 |
| Product codes | NBW, QLG |
| Device names | NBW - System, Test, Blood Glucose, Over The Counter, QLG - Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345, 862.1355 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT DIABETES CARE INC., ABBOTT DIABETES CARE LIMITED |
| Establishment registrations | 2954323, 9710492 |
| FEI numbers | 3002803444, 3003500908 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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