Cleared Traditional

SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS

K050394 · Medtox Diagnostics, Inc. · Chemistry
Oct 2005
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K050394 is an FDA 510(k) clearance for the SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 25, 2005, 251 days after receiving the submission on February 16, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K050394 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2005
Decision Date October 25, 2005
Days to Decision 251 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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