Cleared Traditional

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

K113720 · Randox Laboratories, Ltd. · Chemistry
Sep 2012
Decision
276d
Days
Class 1
Risk

About This 510(k) Submission

K113720 is an FDA 510(k) clearance for the RANDOX MATERNAL CONTROL, LEVELS 1, 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 20, 2012, 276 days after receiving the submission on December 19, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K113720 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2011
Decision Date September 20, 2012
Days to Decision 276 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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