Cleared Traditional

ONLINE VALPROIC ACID

K060690 · Roche Diagnostics Corp. · Toxicology
Aug 2006
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K060690 is an FDA 510(k) clearance for the ONLINE 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 8, 2006, 146 days after receiving the submission on March 15, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K060690 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2006
Decision Date August 08, 2006
Days to Decision 146 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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