Cleared Traditional

RANDOX TRI LEVEL CARDIAC CONTROL

K041361 · Randox Laboratories Limited · Chemistry
Sep 2004
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K041361 is an FDA 510(k) clearance for the RANDOX TRI LEVEL CARDIAC CONTROL, 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 September 9, 2004, 111 days after receiving the submission on May 21, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K041361 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2004
Decision Date September 09, 2004
Days to Decision 111 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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