Product code
QKT: Clozapine test system
FDA product code · Class II · Toxicology
Key facts
| Product code | QKT |
|---|---|
| Device | Clozapine test system |
| Device class | Class II |
| Regulation number | 862.3245 |
| Review panel | Toxicology |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None 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