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Genmark Diagnostics, Incorporated

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

Total Devices7
Categories6
Latest Approval2022-04-27
TypeNumberDevice NameCodeDate
510(k) K213236 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel PEN 2022-04-27 View
510(k) K182619 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel PEN 2019-04-12 View
510(k) K182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel PEO 2018-12-21 View
510(k) K181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel PAM 2018-12-20 View
510(k) K163636 ePlex Respiratory Pathogen Panel OCC 2017-06-09 View
510(k) K163652 ePlex Instrument NSU 2017-06-09 View
510(k) K152612 eSensor Warfarin Sensitivity Saliva Test ODW 2016-05-26 View
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