Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel— 510(k) K191099

Name: FDA 510(k) clearance K191099
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

Substantially Equivalent

Atlas Medical

FDA 510(k) clearance K191099 for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel, Substantially Equivalent on 2019-10-03. Applicant: Atlas Medical. Device class: 2.

Clearance details

Applicant: Atlas Medical
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2019-04-25
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amman, JO

Download summary PDF View on FDA.gov ↗

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