QKT · Class II · 21 CFR 862.3245

FDA Product Code QKT: Clozapine Test System

A Clozapine Test System Is Intended For The In Vitro Quantitative Measurement Of Clozapine In Human Specimens.

Leading manufacturers include Saladax Biomedical, Inc..

1
Total
0
Cleared
328d
Avg days
2020
Since

FDA 510(k) Cleared Clozapine Test System Devices (Product Code QKT)

1 devices
1–1 of 1
Not Cleared Apr 16, 2020
MyCare Psychiatry Clozapine Assay Kit
DEN190028
Saladax Biomedical, Inc.
Toxicology · 328d

About Product Code QKT - Regulatory Context