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FDA 510(k)

ePlex Instrument

K-Number: K163652 · 2017-06-09

ApplicantGenmark Diagnostics, Incorporated
Decision Date2017-06-09
Product CodeNSU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the ePlex Instrument?

ePlex Instrument 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 K163652.

When was ePlex Instrument approved by the FDA?

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

What company makes ePlex Instrument?

ePlex Instrument is manufactured by Genmark Diagnostics, Incorporated.

What is the FDA product code for ePlex Instrument?

The FDA product code for ePlex Instrument is NSU.

Other Devices by Genmark Diagnostics, Incorporated

K152612eSensor Warfarin Sensitivity Saliva Test K163636ePlex Respiratory Pathogen Panel K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

View all 7 devices →

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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