Great Basin Scientific, Inc.
FDA Regulatory Profile
Great Basin Scientific, Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1051-2017, Class II) was initiated on December 12, 2016. Its most recent 510(k) clearance was granted on July 12, 2017.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1051-2017 | Class II | Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qu | December 12, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163571 | Great Basin Stool Bacterial Pathogens Panel | July 12, 2017 |
| K170284 | Great Basin Bordetella Direct Test | March 31, 2017 |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | March 25, 2016 |
| K152955 | Great Basin Shiga Toxin Direct Test | March 22, 2016 |
| DEN120013 | PORTRAIT ANALYZER | April 30, 2012 |