Product code
LXG: Equipment, laboratory, general purpose, labeled or promoted for a specific medical use
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | LXG |
|---|---|
| Device | Equipment, laboratory, general purpose, labeled or promoted for a specific medical use |
| Device class | Class I |
| Regulation number | 862.2050 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 10–99 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database