Cleared Traditional

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

K091653 · ARK Diagnostics, Inc. · Toxicology
Nov 2009
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K091653 is an FDA 510(k) clearance for the ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00, a Levetiracetam Assay (Class II — Special Controls, product code ORI), submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 2, 2009, 146 days after receiving the submission on June 9, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K091653 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2009
Decision Date November 02, 2009
Days to Decision 146 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code ORI — Levetiracetam Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350
Definition For The Quantitative Determination Of Levetiracetam In Human Serum Or Plasma.