FDA device listing
SillHa LH-4912 Oral Wellness System,SillHa paper Test Strip Kit
FDA device listing 1344439273 · ARKRAY FACTORY USA, Inc.
Key facts
| Proprietary names | SillHa LH-4912 Oral Wellness System,SillHa paper Test Strip Kit |
|---|---|
| Owner/operator | ARKRAY FACTORY USA, Inc. |
| Owner/operator number | 8030316 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | ARKRAY Factory, Inc., ARKRAY FACTORY USA, INC., ARKRAY, INC. |
| Establishment registrations | 1832816, 9611444, 3003422726 |
| FEI numbers | 1832816, 3002807423, 3003422726 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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