FDA 510(k) Applications Submitted by GenMark Diagnostics, Incorporated

FDA 510(k) Number	Submission Date	Device Name	Applicant
K181663	06/25/2018	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	GenMark Diagnostics, Incorporated
K152612	09/14/2015	eSensor Warfarin Sensitivity Saliva Test	GENMARK DIAGNOSTICS, INCORPORATED
K182619	09/24/2018	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	GenMark Diagnostics, Incorporated
K213236	09/30/2021	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	GenMark Diagnostics, Incorporated
K163636	12/22/2016	ePlex Respiratory Pathogen Panel	GENMARK DIAGNOSTICS, INCORPORATED
K163652	12/23/2016	ePlex Instrument	GenMark Diagnostics, Incorporated
K182690	09/27/2018	ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	GenMark Diagnostics, Incorporated