510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232522Substantially Equivalent

ARK Levetiracetam II Assay

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

K232522 is the FDA 510(k) clearance record for ARK Levetiracetam II Assay, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code ORI (Levetiracetam Assay). FDA's definition for product code ORI reads: "For the quantitative determination of levetiracetam in human serum or plasma". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K232522.

Clearance record

Decision date
Received
(193 days to decision)
Product code
ORI Levetiracetam Assay
Regulation
21 CFR 862.3350
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 ORI

Trailing 12 months

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

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