# Genmark Diagnostics, Incorporated

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 8 (2011–2022): 8 510(k) clearances
- Names in FDA's records: Genmark Diagnostics, Incorporated (7); GenMark Diagnostics, Inc. (1)
- Product codes: PEN (2), NSU (2), PAM (1), PEO (1), OCC (1), ODW (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 3 (https://510kreport.com/company/biofire-diagnostics)
- Osmetech Molecular Diagnostics: 1 (https://510kreport.com/company/osmetech-molecular-diagnostics)

## Firms that cite its devices most
- QIAGEN GmbH: 3 (https://510kreport.com/company/qiagen)
- Luminex Corporation: 1 (https://510kreport.com/company/luminex)

## Its most-cited devices
- K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (2018), cited by 2
- K182619: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (2019), cited by 2
- K181663: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (2018), cited by 1
- K110786: Esensor Warfarin Sensitivity Saliva Test (2011), cited by 1

## Recent decisions
- K213236: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (Apr 27, 2022)
- K182619: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (Apr 12, 2019)
- K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (Dec 21, 2018)
- K181663: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (Dec 20, 2018)
- K163636: ePlex Respiratory Pathogen Panel (Jun 9, 2017)
- K163652: ePlex Instrument (Jun 9, 2017)
- K152612: eSensor Warfarin Sensitivity Saliva Test (May 26, 2016)
- K110786: Esensor Warfarin Sensitivity Saliva Test (Dec 2, 2011)

Source page: https://510kreport.com/company/genmark-diagnostics