Cleared Traditional

RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

K140522 · Randox Laboratories Limited · Chemistry
May 2014
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K140522 is an FDA 510(k) clearance for the RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL 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 May 22, 2014, 79 days after receiving the submission on March 4, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K140522 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2014
Decision Date May 22, 2014
Days to Decision 79 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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