Cleared Special

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

K031870 · Beckman Coulter, Inc. · Toxicology
Jul 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K031870 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on July 15, 2003, 28 days after receiving the submission on June 17, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K031870 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2003
Decision Date July 15, 2003
Days to Decision 28 days
Submission Type Special
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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