PUJ · Class II · 21 CFR 862.3970

FDA Product Code PUJ: Voriconazole Test System

A Voriconazole Test System Is A Device Intended To Measure Voriconazole In Human Serum. Measurements Obtained By This Device Are Used In Monitoring Levels Of Voriconazole To Ensure Appropriate Therapy.

Leading manufacturers include ARK Diagnostics, Inc..

1
Total
0
Cleared
294d
Avg days
2017
Since

FDA 510(k) Cleared Voriconazole Test System Devices (Product Code PUJ)

1 devices
1–1 of 1
Not Cleared May 05, 2017
ARK Voriconazole II Assay Test System
DEN160033
ARK Diagnostics, Inc.
Toxicology · 294d

About Product Code PUJ - Regulatory Context