Cleared Traditional

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

K101305 · ARK Diagnostics, Inc. · Toxicology

Oct 2010

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K101305 is an FDA 510(k) clearance for the ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL, a Lamotrigine Assay (Class II — Special Controls, product code ORH), submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 29, 2010, 172 days after receiving the submission on May 10, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K101305 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2010
Decision Date	October 29, 2010
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	ORH — Lamotrigine Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350
Definition	For The Quantitative Determination Of Lamotrigine In Human Serum Or Plasma On Automated Clinical Chemistry Analyzers.