Cleared Traditional

RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

K110904 · Randox Laboratories, Ltd. · Chemistry
Sep 2011
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K110904 is an FDA 510(k) clearance for the RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3, 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 September 30, 2011, 183 days after receiving the submission on March 31, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K110904 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2011
Decision Date September 30, 2011
Days to Decision 183 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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