Cleared Traditional

SERADYN QMS TOPIRAMATE

K070645 · Seradyn, Inc. · Toxicology

May 2007

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K070645 is an FDA 510(k) clearance for the SERADYN QMS TOPIRAMATE, 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 May 17, 2007, 70 days after receiving the submission on March 8, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K070645 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2007
Decision Date	May 17, 2007
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
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.