Cleared Traditional

ROCHE ONLINE TDM VALPROIC ACID

K032049 · Roche Diagnostics Corp. · Toxicology
Aug 2003
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K032049 is an FDA 510(k) clearance for the ROCHE ONLINE TDM VALPROIC ACID, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 22, 2003, 51 days after receiving the submission on July 2, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K032049 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2003
Decision Date August 22, 2003
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LEG — Enzyme Immunoassay, Valproic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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