Cleared Traditional

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

K062966 · Seradyn, Inc. · Chemistry
Jan 2007
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K062966 is an FDA 510(k) clearance for the QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS, a Lamotrigine Assay (Class II — Special Controls, product code ORH), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2007, 105 days after receiving the submission on September 29, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K062966 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2006
Decision Date January 12, 2007
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
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.