Product code
LPJ: Kit, assay, estrogen receptor
FDA product code · Class III · Clinical Chemistry
Key facts
| Product code | LPJ |
|---|---|
| Device | Kit, assay, estrogen receptor |
| Device class | Class III |
| Regulation number | 864.1860 |
| Review panel | Clinical Chemistry |
| Medical specialty | Hematology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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