Company ยท US
Great Basin Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2017. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 2 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 |
| OZZ | Bordetella Pertussis Dna Assay System | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2017 | K163571 | Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. | PCI |
| Mar 31, 2017 | K170284 | Great Basin Bordetella Direct Test Great Basin Scientific, Inc. | OZZ |
| Mar 25, 2016 | K152470 | Great Basin Staph ID/R Blood Culture Panel Great Basin Scientific, Inc. | PAM |
| Mar 22, 2016 | K152955 | Great Basin Shiga Toxin Direct Test Great Basin Scientific, Inc. | PCH |
| Apr 30, 2012 | DEN120013 | PORTRAIT ANALYZER Great Basin Scientific | OMN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2017 | Great Basin Scientific, Inc. Great Basin Staph lD/R Blood Culture Panel
The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer Sys Terminated |
PAM | K152470 |