Cleared Traditional

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

K051211 · Seradyn, Inc. · Chemistry

Nov 2005

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K051211 is an FDA 510(k) clearance for the QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS, a Immunoassay, Anti-seizure Drug (Class II — Special Controls, product code NWM), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 18, 2005, 191 days after receiving the submission on May 11, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K051211 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2005
Decision Date	November 18, 2005
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NWM — Immunoassay, Anti-seizure Drug
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350
Definition	To Aid In Management Of Patients Treated With Anti-seizure Drug.