Cleared Traditional

MODEL 5500 CEAS

K934977 · Esa, Inc. · Chemistry
Jan 1994
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K934977 is an FDA 510(k) clearance for the MODEL 5500 CEAS, a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on January 11, 1994, 84 days after receiving the submission on October 19, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number K934977 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1993
Decision Date January 11, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDF — Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1795

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