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
K153596Substantially Equivalent

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

Ark Diagnostics Inc, Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153596 is the FDA 510(k) clearance record for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code POX (Enzyme Immunoassay, Oxcarbazepine Metabolite). FDA's definition for product code POX reads: "An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help...". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K153596.

Clearance record

Decision date
Received
(237 days to decision)
Product code
POX Enzyme Immunoassay, Oxcarbazepine Metabolite
Regulation
21 CFR 862.3645
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ark Diagnostics, Inc. 48089 Fremont Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POX

Trailing 12 months

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

FDA records show no clearances under product code POX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code POX, 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