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FDA 510(k)

ePlex Respiratory Pathogen Panel

K-Number: K163636 · 2017-06-09

ApplicantGenmark Diagnostics, Incorporated
Decision Date2017-06-09
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ePlex Respiratory Pathogen Panel is a medical device manufactured by Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2017-06-09 under approval number K163636. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Genmark Diagnostics, Incorporated. The 510(k) number is K163636.

When was ePlex Respiratory Pathogen Panel approved by the FDA?

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

What company makes ePlex Respiratory Pathogen Panel?

ePlex Respiratory Pathogen Panel is manufactured by Genmark Diagnostics, Incorporated.

What is the FDA product code for ePlex Respiratory Pathogen Panel?

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

Other Devices by Genmark Diagnostics, Incorporated

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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.

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