Genmark Diagnostics, Incorporated is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genmark Diagnostics, Incorporated - FDA 510(k) Cleared Devices
Recent clearances: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
7
Total
7
Cleared
0
Denied
Genmark Diagnostics, Incorporated has 7 FDA 510(k) cleared medical devices. Based in Carlsbad, US.
Last cleared in 2022. Active since 2016. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Genmark Diagnostics, Incorporated Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genmark Diagnostics, Incorporated
7 devices
Cleared
Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Microbiology
209d
Cleared
Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Microbiology
200d
Cleared
Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
Microbiology
85d
Cleared
Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
Microbiology
178d
Cleared
Jun 09, 2017
ePlex Respiratory Pathogen Panel
Microbiology
169d
Cleared
Jun 09, 2017
ePlex Instrument
Microbiology
168d
Cleared
May 26, 2016
eSensor Warfarin Sensitivity Saliva Test
Chemistry
255d