The following data is part of a premarket notification filed by Great Basin Scientific, Inc. with the FDA for Great Basin Staph Id/r Blood Culture Panel.
| Device ID | K152470 |
| 510k Number | K152470 |
| Device Name: | Great Basin Staph ID/R Blood Culture Panel |
| Classification | Gram-positive Bacteria And Their Resistance Markers |
| Applicant | GREAT BASIN SCIENTIFIC, INC. 2441 S. 3850 West Salt Lake City, UT 84120 |
| Contact | Chuck Owen |
| Correspondent | Chuck Owen GREAT BASIN SCIENTIFIC, INC. 2441 S. 3850 West Salt Lake City, UT 84120 |
| Product Code | PAM |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-03-25 |
| Summary: | summary |