FDA 510(k)

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

N.º K: K191099 · 2019-10-03

Fecha de decisión2019-10-03

Código de productoDKZ

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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