Cleared Traditional

CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET

K092269 · Randox Laboratories, Ltd. · Toxicology
Apr 2011
Decision
619d
Days
Class 2
Risk

About This 510(k) Submission

K092269 is an FDA 510(k) clearance for the CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on April 8, 2011, 619 days after receiving the submission on July 28, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K092269 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2009
Decision Date April 08, 2011
Days to Decision 619 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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