FDA product code QKT: Clozapine Test System
QKT is the FDA product code for clozapine test system. It is a Class II device, regulated under 21 CFR 862.3245 and reviewed by the Clinical Toxicology panel. Devices under QKT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
Classification
| Field | Value |
|---|---|
| Device name | Clozapine Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3245 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for QKT devices
openFDA lists no recalls for product code QKT.
Frequently asked questions
What is FDA product code QKT?
QKT is the FDA product code for clozapine test system. It is a Class II device, regulated under 21 CFR 862.3245 and reviewed by the Clinical Toxicology panel.
What device class is QKT?
Class II, regulation 21 CFR 862.3245. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QKT
- Run a recall and safety report across every QKT manufacturer
- Watch product code QKT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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