Company ยท US
Genmark Diagnostics, Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | 2 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 1 |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2022 | K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel Genmark Diagnostics, Incorporated | PEN |
| Apr 12, 2019 | K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel Genmark Diagnostics, Incorporated | PEN |
| Dec 21, 2018 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel Genmark Diagnostics, Incorporated | PEO |
| Dec 20, 2018 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel Genmark Diagnostics, Incorporated | PAM |
| Jun 9, 2017 | K163652 | ePlex Instrument Genmark Diagnostics, Incorporated | NSU |
| Jun 9, 2017 | K163636 | ePlex Respiratory Pathogen Panel Genmark Diagnostics, Incorporated | OCC |
| May 26, 2016 | K152612 | eSensor Warfarin Sensitivity Saliva Test Genmark Diagnostics, Incorporated | ODW |
| Dec 2, 2011 | K110786 | ESENSOR WARFARIN SENSITIVITY SALIVA TEST GenMark Diagnostics, Inc. | NSU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||