The following data is part of a premarket notification filed by Great Basin Scientific, Inc. with the FDA for Great Basin Bordetella Direct Test.
| Device ID | K170284 |
| 510k Number | K170284 |
| Device Name: | Great Basin Bordetella Direct Test |
| Classification | Bordetella Pertussis Dna Assay System |
| Applicant | GREAT BASIN SCIENTIFIC, INC. 2441 S. 3850 WEST SUITE 100 Salt Lake City, UT 84120 |
| Contact | Suzette Chance |
| Correspondent | Suzette Chance GREAT BASIN SCIENTIFIC, INC. 2441 S. 3850 WEST SUITE 100 Salt Lake City, UT 84120 |
| Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-03-31 |
| Summary: | summary |