510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QKTClass II

Clozapine Test System

21 CFR 862.3245 / Clinical Chemistry
FDA source (opens on fda.gov)

QKT is the FDA product code for Clozapine Test System, a class II device type, regulated under 21 CFR 862.3245. FDA's definition for this code reads: "A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QKT
Device name
Clozapine Test System
FDA definition
A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
Regulation
21 CFR 862.3245
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QKT

By decision year
1 clearance under product code QKT with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QKT by decision year
YearClearances
20201

Applicants with the most clearances

Product code QKT
Applicants holding the most 510(k) clearances under product code QKT
ApplicantClearances
Saladax Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code