Cleared Traditional

RANDOX ECSTASY (MDMA) ASSAY

K092275 · Randox Laboratories, Ltd. · Chemistry
Mar 2011
Decision
581d
Days
Class 2
Risk

About This 510(k) Submission

K092275 is an FDA 510(k) clearance for the RANDOX ECSTASY (MDMA) ASSAY, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on March 1, 2011, 581 days after receiving the submission on July 28, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K092275 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2009
Decision Date March 01, 2011
Days to Decision 581 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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