Cleared Traditional

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

K110534 · Randox Laboratories Limited · Chemistry
Jan 2012
Decision
332d
Days
Class 1
Risk

About This 510(k) Submission

K110534 is an FDA 510(k) clearance for the RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 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 January 23, 2012, 332 days after receiving the submission on February 25, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K110534 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2011
Decision Date January 23, 2012
Days to Decision 332 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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