Cleared Traditional

ELECTROPHORESIS CONTROL LEVEL 1

K925326 · Seradyn, Inc. · Chemistry
Mar 1993
Decision
156d
Days
Class 1
Risk

About This 510(k) Submission

K925326 is an FDA 510(k) clearance for the ELECTROPHORESIS CONTROL LEVEL 1, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 26, 1993, 156 days after receiving the submission on October 21, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K925326 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1992
Decision Date March 26, 1993
Days to Decision 156 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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