Cleared Traditional

RANDOX METHAMPHETAMINE ASSAY

K092266 · Randox Laboratories, Ltd. · Toxicology
May 2011
Decision
650d
Days
Class 2
Risk

About This 510(k) Submission

K092266 is an FDA 510(k) clearance for the RANDOX METHAMPHETAMINE ASSAY, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on May 9, 2011, 650 days after receiving the submission on July 28, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K092266 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2009
Decision Date May 09, 2011
Days to Decision 650 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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