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Genmark Diagnostics, Incorporated

7 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236)Genmark Diagnostics, Incorporated2022-04-27
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K182619)Genmark Diagnostics, Incorporated2019-04-12
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (K182690)Genmark Diagnostics, Incorporated2018-12-21
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663)Genmark Diagnostics, Incorporated2018-12-20
ePlex Instrument (K163652)Genmark Diagnostics, Incorporated2017-06-09
ePlex Respiratory Pathogen Panel (K163636)Genmark Diagnostics, Incorporated2017-06-09
eSensor Warfarin Sensitivity Saliva Test (K152612)Genmark Diagnostics, Incorporated2016-05-26

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Every clearance here is in the API, with alerts when new ones post.