FDA 510(k)

ePlex Respiratory Pathogen Panel

Número K: K163636 · 2017-06-09

RequerenteGenmark Diagnostics, Incorporated

Data da decisão2017-06-09

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ePlex Respiratory Pathogen Panel 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 K163636. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ePlex Respiratory Pathogen Panel?

ePlex Respiratory Pathogen Panel 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 K163636.

When did ePlex Respiratory Pathogen Panel receive FDA 510(k) clearance?

ePlex Respiratory Pathogen Panel received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163636.

Who is the listed applicant for ePlex Respiratory Pathogen Panel?

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 Respiratory Pathogen Panel?

The FDA product code for ePlex Respiratory Pathogen Panel is OCC.

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