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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Atlas Medical. It received FDA 510(k) clearance on 2019-10-03 under 510(k) 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. The listed applicant is Atlas Medical. The 510(k) number is K191099.

When did Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel receive FDA 510(k) clearance?

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191099.

Who is the listed applicant for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

The FDA 510(k) record lists Atlas Medical as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07668193GlaukomAI: Clinical Validation of an AI System for Early Glaucoma ScreeningNOT_YET_RECRUITING

Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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