DeviceClearance

Product code QKT— Clinical Chemistry

MyCare Psychiatry Clozapine Assay Kit

Classification name
Clozapine Test System
Device class
Class 2
Regulation
21 CFR 862.3245
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QKT under 21 CFR 862.3245, via openFDA

Market context for product code QKT

FDA has cleared 1 device under product code QKT, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QKT

Recent clearances under product code QKT

Data sourced from openFDA. This site is unofficial and independent of the FDA.