Cleared Traditional

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

K083799 · ARK Diagnostics, Inc. · Toxicology
Apr 2009
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K083799 is an FDA 510(k) clearance for the TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00, a Immunoassay, Anti-seizure Drug (Class II — Special Controls, product code NWM), submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 16, 2009, 115 days after receiving the submission on December 22, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K083799 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2008
Decision Date April 16, 2009
Days to Decision 115 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.