510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PUJClass II

Voriconazole Test System

21 CFR 862.3970 / Clinical Toxicology
FDA source (opens on fda.gov)

PUJ is the FDA product code for Voriconazole Test System, a class II device type, regulated under 21 CFR 862.3970. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PUJ
Device name
Voriconazole Test System
FDA definition
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.
Regulation
21 CFR 862.3970
Device class
Class II
Review panel
Clinical Toxicology
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 PUJ

By decision year
1 clearance under product code PUJ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUJ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PUJ
Applicants holding the most 510(k) clearances under product code PUJ
ApplicantClearances
Ark Diagnostics Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code