Cleared Traditional

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM

K931148 · Esa, Inc. · Chemistry
Jun 1993
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K931148 is an FDA 510(k) clearance for the MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM, a Chromatographic/fluorometric Method, Catecholamines (Class I — General Controls, product code CHQ), submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on June 9, 1993, 96 days after receiving the submission on March 5, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number K931148 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1993
Decision Date June 09, 1993
Days to Decision 96 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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