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Genmark Diagnostics, Incorporated

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories6
Latest FDA decision2022-04-27
TypeNumberDevice NameCodeDateActions
510(k) K213236 ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN2022-04-27 View
510(k) K182619 ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN2019-04-12 View
510(k) K182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelPEO2018-12-21 View
510(k) K181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM2018-12-20 View
510(k) K163636 ePlex Respiratory Pathogen PanelOCC2017-06-09 View
510(k) K163652 ePlex InstrumentNSU2017-06-09 View
510(k) K152612 eSensor Warfarin Sensitivity Saliva TestODW2016-05-26 View
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