Cleared Traditional

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

K191099 · Atlas Medical · Toxicology
Oct 2019
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K191099 is an FDA 510(k) clearance for the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Atlas Medical (Amman, JO). The FDA issued a Cleared decision on October 3, 2019, 161 days after receiving the submission on April 25, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K191099 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2019
Decision Date October 03, 2019
Days to Decision 161 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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