Genmark Diagnostics, Incorporated
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 27, 2022 |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 12, 2019 |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | December 21, 2018 |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | December 20, 2018 |
| K163636 | ePlex Respiratory Pathogen Panel | June 9, 2017 |
| K163652 | ePlex Instrument | June 9, 2017 |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | May 26, 2016 |