FDA device listing
Accu-Chek Guide Link Blood Glucose Monitoring System,Accu-Chek Guide Link FC US MG/DL,Accu-Chek Guide Link Replacement…
FDA device listing 1641018977 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Accu-Chek Guide Link Blood Glucose Monitoring System,Accu-Chek Guide Link FC US MG/DL,Accu-Chek Guide Link Replacement Kit US |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | P160017 |
| Product codes | OZP |
| Device names | OZP - Automated Insulin Dosing Device System, Single Hormonal Control |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OZP |
| 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
- 100–999 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