510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160033Unknown

ARK Voriconazole II Assay Test System

Ark Diagnostics Inc, Fremont CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160033 is the FDA 510(k) clearance record for ARK Voriconazole II Assay Test System, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code PUJ (Voriconazole Test System). FDA's definition for product code PUJ 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". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming DEN160033.

Clearance record

Decision date
Received
(294 days to decision)
Product code
PUJ Voriconazole Test System
Regulation
21 CFR 862.3970
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ark Diagnostics, Inc. 48089 Fremont Blvd., Fremont CA
Third party review
No

Clearances, product code PUJ

Trailing 12 months

FDA records hold no clearances under product code PUJ in the trailing twelve months.

FDA records show no clearances under product code PUJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PUJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260