The following data is part of a premarket notification filed by Great Basin Scientific, Inc. with the FDA for Great Basin Stool Bacterial Pathogens Panel.
| Device ID | K163571 |
| 510k Number | K163571 |
| Device Name: | Great Basin Stool Bacterial Pathogens Panel |
| Classification | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Great Basin Scientific, Inc. 2441 S. 3850 West Salt Lake City, UT 84120 |
| Contact | Suzette Chance |
| Correspondent | Suzette Chance Great Basin Scientific, Inc. 2441 S. 3850 West Salt Lake City, UT 84120 |
| Product Code | PCI |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-07-12 |
| Summary: | summary |