The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Blood Culture Identification Gram Negative (bcid-gn) Panel.
| Device ID | K213236 |
| 510k Number | K213236 |
| Device Name: | EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
| Contact | Alan Maderazo |
| Correspondent | Alan Maderazo GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
| Product Code | PEN |
| Subsequent Product Code | PAM |
| Subsequent Product Code | PEO |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-04-27 |