Genmark Diagnostics, Incorporated - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) cleared devices by Genmark Diagnostics, Incorporated Microbiology ✕
6 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