Cleared Traditional

RANDOX BARITURATES ASSAY

K092268 · Randox Laboratories, Ltd. · Toxicology
May 2011
Decision
666d
Days
Class 2
Risk

About This 510(k) Submission

K092268 is an FDA 510(k) clearance for the RANDOX BARITURATES ASSAY, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on May 25, 2011, 666 days after receiving the submission on July 28, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K092268 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2009
Decision Date May 25, 2011
Days to Decision 666 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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