Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K-Number: K191099 · 2019-10-03
ApplicantAtlas Medical
Decision Date2019-10-03
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is a medical device manufactured by Atlas Medical. It received FDA 510(k) clearance on 2019-10-03 under approval number K191099. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Atlas Medical. The 510(k) number is K191099.
When was Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel approved by the FDA?
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel received FDA 510(k) clearance on 2019-10-03, under approval number K191099.
What company makes Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is manufactured by Atlas Medical.
What is the FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?
The FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is DKZ.
Related Clinical Trials
NCT07195591
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
RECRUITING
NCT07603752
Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study
RECRUITING
NCT06204614
Drug Screening Using IMD in Bladder Cancer
ENROLLING_BY_INVITATION
NCT04921488
Interest of Artificial Intelligence in Cancer Screening Colonoscopy
COMPLETED
NCT05155605
PATHFINDER 2: A Multi-Cancer Early Detection Study
ACTIVE_NOT_RECRUITING
NCT01036581
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
RECRUITING
Related PubMed Literature
PMID: 42212181
Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework.
Journal of multidisciplinary healthcare (2026)
PMID: 42119715
Integrated chemical and molecular authentication of Pinellia tuber: A multinational collaboration within the FHH ATLAS project with government regulatory agencies from seven countries and regions.
Fitoterapia (2026)
PMID: 40886259
BRCA-CN: a blockchain-based framework to support public variant databases sharing in multi-center community for diagnostic reference and China regulatory science.
Human genetics (2025)
Related Devices (Code: DKZ)
K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsHangzhou Clongene Biotech Co., Ltd.
K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)Alfa Scientific Designs, Inc.
K152908UCP COMPACT DRUG TESTSUcp Biosciences, Inc.
K152590ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc.
K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd.
K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx UseShanghai Venture Bio-Tech Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.