Cleared Traditional

RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL

K112337 · Randox Laboratories, Ltd. · Chemistry
Dec 2011
Decision
108d
Days
Class 1
Risk

About This 510(k) Submission

K112337 is an FDA 510(k) clearance for the RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on December 1, 2011, 108 days after receiving the submission on August 15, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K112337 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2011
Decision Date December 01, 2011
Days to Decision 108 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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