Cleared Traditional

RANDOX CSF CONTROLS LEVELS 2 AND 3

K132156 · Randox Laboratories, Ltd. · Chemistry
Oct 2013
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K132156 is an FDA 510(k) clearance for the RANDOX CSF CONTROLS LEVELS 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 October 23, 2013, 104 days after receiving the submission on July 11, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K132156 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2013
Decision Date October 23, 2013
Days to Decision 104 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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