FDA device listing
FORA GD50 Blood Glucose Monitoring System,FORA Test N'GO Voice Blood Glucose Monitoring System,FORA TN'G Voice Blood…
FDA device listing 1281195025 · Fora Care Inc.
Key facts
| Proprietary names | FORA GD50 Blood Glucose Monitoring System,FORA Test N'GO Voice Blood Glucose Monitoring System,FORA TN'G Voice Blood Glucose Monitoring System |
|---|---|
| Owner/operator | Fora Care Inc. |
| Owner/operator number | 10026431 |
| Premarket submissions | K100322 |
| Product codes | JJX, LFR, NBW |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LFR - Glucose Dehydrogenase, Glucose, NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1345, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | FORA CARE INC. |
| Establishment registrations | 3007134734 |
| FEI numbers | 3007134734 |
| Establishment operations | Complaint File Establishment |
| 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