Cleared Traditional

RANDOX OPIATES ASSAY

K113747 · Randox Laboratories Limited · Chemistry
Aug 2012
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K113747 is an FDA 510(k) clearance for the RANDOX OPIATES ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on August 24, 2012, 248 days after receiving the submission on December 20, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K113747 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2011
Decision Date August 24, 2012
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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