Cleared Traditional

RANDOX COCAINE METABOLITE

K113751 · Randox Laboratories, Ltd. · Chemistry
May 2012
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K113751 is an FDA 510(k) clearance for the RANDOX COCAINE METABOLITE, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on May 8, 2012, 139 days after receiving the submission on December 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K113751 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2011
Decision Date May 08, 2012
Days to Decision 139 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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