Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Applications Submitted by GENMARK DIAGNOSTICS, INCORPORATED
FDA 510(k) Number
Submission Date
Device Name
Applicant
K181663
06/25/2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
GenMark Diagnostics, Incorporated
K152612
09/14/2015
eSensor Warfarin Sensitivity Saliva Test
GENMARK DIAGNOSTICS, INCORPORATED
K182619
09/24/2018
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
GenMark Diagnostics, Incorporated
K213236
09/30/2021
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
GenMark Diagnostics, Incorporated
K163636
12/22/2016
ePlex Respiratory Pathogen Panel
GENMARK DIAGNOSTICS, INCORPORATED
K163652
12/23/2016
ePlex Instrument
GenMark Diagnostics, Incorporated
K182690
09/27/2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
GenMark Diagnostics, Incorporated
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact