FDA device listing
AlcoMate AccuCell AL9000,AlcoMate AL2500,AlcoMate AL2500 Elite,AlcoMate Core AL6000,AlcoMate Premium AL7000,AlcoMate…
FDA device listing 1812707537 · AK GlobalTech Corp
Key facts
| Proprietary names | AlcoMate AccuCell AL9000,AlcoMate AL2500,AlcoMate AL2500 Elite,AlcoMate Core AL6000,AlcoMate Premium AL7000,AlcoMate Premium Sensor Module SM7000,AlcoMate Prestige AL6000,AlcoMate Prestige Sensor Module SM6000,AlcoMate Revo Sensor Module SM200,AlcoMate Revo TS200,AlcoMate Sensor Module SM4000,AlcoMate TS100,AlcoMate TS600,AlcoScan AL3100,AlcoScan AL3500,AlcoScan AL4000,AlcoScan Sensor Module… |
|---|---|
| Owner/operator | AK GlobalTech Corp |
| Owner/operator number | 10034445 |
| Product codes | DJZ |
| Device names | DJZ - Devices, Breath Trapping, Alcohol |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3050 |
| Review panels | Clinical Toxicology |
| Registered establishments | AK GLOBALTECH CORP |
| Establishment registrations | 3004077604 |
| FEI numbers | 3004077604 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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