FDA device listing
CAREONE Express Blood Glucose Monitoring System,D-Care,Diathrive Blood Glucose Monitoring System,Leader LE1,On Call…
FDA device listing 1908089227 · ACON Laboratories, Inc.
Key facts
| Proprietary names | CAREONE Express Blood Glucose Monitoring System,D-Care,Diathrive Blood Glucose Monitoring System,Leader LE1,On Call Express Blood Glucose Monitoring System |
|---|---|
| Owner/operator | ACON Laboratories, Inc. |
| Owner/operator number | 9063887 |
| Premarket submissions | K132086 |
| Product codes | CGA, JJX, NBW |
| Device names | CGA - Glucose Oxidase, Glucose, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), 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 | ACON LABORATORIES, INC. |
| Establishment registrations | 2531491 |
| FEI numbers | 3003516723 |
| Establishment operations | Manufacturer, Specification Developer |
| 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