Cleared Traditional

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

K140971 · Randox Laboratories Limited · Chemistry
Dec 2014
Decision
236d
Days
Class 1
Risk

About This 510(k) Submission

K140971 is an FDA 510(k) clearance for the LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3., a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on December 8, 2014, 236 days after receiving the submission on April 16, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K140971 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2014
Decision Date December 08, 2014
Days to Decision 236 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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