QKT

Clozapine Test System

Product code: QKT
Device name: Clozapine Test System
Device class: Class 2
21 CFR: 21 CFR 862.3245
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QKT

Classification and pathway per current FDA publications. Data from openFDA (CC0).