The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Blood Culture Identification Panel Fungal Pathogen (bcid-fp) Panel.
| Device ID | K182690 |
| 510k Number | K182690 |
| Device Name: | EPlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel |
| Classification | Fungal Organisms, Nucleic Acid-based Assay |
| Applicant | GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
| Contact | Beth Stofka |
| Correspondent | Beth Stofka GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
| Product Code | PEO |
| Subsequent Product Code | PAM |
| Subsequent Product Code | PEN |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857167005290 | K182690 | 000 |
| 00857167005283 | K182690 | 000 |