The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Instrument.
| Device ID | K163652 |
| 510k Number | K163652 |
| Device Name: | EPlex Instrument |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| 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 | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857167005009 | K163652 | 000 |