510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101305Substantially Equivalent

Ark Lamotrigine Assay, Calibrator & Control

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

K101305 is the FDA 510(k) clearance record for ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code ORH (Lamotrigine Assay). FDA's definition for product code ORH reads: "for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K101305.

Clearance record

Decision date
Received
(172 days to decision)
Product code
ORH Lamotrigine Assay
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ark Diagnostics, Inc. 1190 Bordeaux Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORH

Trailing 12 months

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

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