FDA 510(k)

ePlex Instrument

Número K: K163652 · 2017-06-09

RequerenteGenmark Diagnostics, Incorporated

Data da decisão2017-06-09

Código do produtoNSU

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ePlex Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K163652. The device is classified under product code NSU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ePlex Instrument?

ePlex Instrument is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K163652.

When did ePlex Instrument receive FDA 510(k) clearance?

ePlex Instrument received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163652.

Who is the listed applicant for ePlex Instrument?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ePlex Instrument?

The FDA product code for ePlex Instrument is NSU.

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Fonte oficial

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