FDA device listing
Seven Hills Pharmacy
FDA device listing 1513722698 · Seven Hills Pharmacy LLC
Key facts
| Proprietary names | Seven Hills Pharmacy |
|---|---|
| Owner/operator | Seven Hills Pharmacy LLC |
| Owner/operator number | 10086907 |
| Premarket submissions | K191833 |
| Product codes | QII |
| Device names | QII - Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1355 |
| Review panels | Clinical Chemistry |
| Registered establishments | SEVEN HILLS PHARMACY LLC |
| Establishment registrations | 3026032436 |
| FEI numbers | 3026032436 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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