Cleared Traditional

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

K110846 · Randox Laboratories Limited · Chemistry
Sep 2011
Decision
186d
Days
Class 1
Risk

About This 510(k) Submission

K110846 is an FDA 510(k) clearance for the RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on September 30, 2011, 186 days after receiving the submission on March 28, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K110846 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date September 30, 2011
Days to Decision 186 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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