Cleared Traditional

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

K121603 · Randox Laboratories, Ltd. · Chemistry
Nov 2012
Decision
228d
Days
Class 1
Risk

About This 510(k) Submission

K121603 is an FDA 510(k) clearance for the RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 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 November 20, 2012, 228 days after receiving the submission on April 6, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K121603 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2012
Decision Date November 20, 2012
Days to Decision 228 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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