Cleared Traditional

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

K032199 · Esa, Inc. · Chemistry
Jan 2004
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K032199 is an FDA 510(k) clearance for the ESA PLASMA FREE METANEPHRINE ANALYSIS KIT, a Chromatographic/fluorometric Method, Catecholamines (Class I — General Controls, product code CHQ), submitted by Esa, Inc. (Chelmsford, US). The FDA issued a Cleared decision on January 30, 2004, 196 days after receiving the submission on July 18, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number K032199 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2003
Decision Date January 30, 2004
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHQ — Chromatographic/fluorometric Method, Catecholamines
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1165

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