Great Basin Scientific, Inc.: FDA clearances and approvals
Great Basin Scientific, Inc. has 4 FDA 510(k) clearances (first 2016, latest 2017), plus 1 De Novo decision, across 5 product codes in 1 review panel. Median 510(k) review time: 186 days. openFDA lists 1 product recall by a recalling firm named Great Basin Scientific, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 187 |
| 2017 | 2 | 132 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Great Basin Scientific, Inc.'s cleared 510(k)s took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | 0 |
| OZZ | Bordetella Pertussis Dna Assay System | 1 | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 | 1 |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Great Basin Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163571 | Great Basin Stool Bacterial Pathogens Panel | PCI | 2017-07-12 | 205 |
| K170284 | Great Basin Bordetella Direct Test | OZZ | 2017-03-31 | 60 |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | PAM | 2016-03-25 | 207 |
| K152955 | Great Basin Shiga Toxin Direct Test | PCH | 2016-03-22 | 167 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120013 | De Novo | C. Difficile Nucleic Acid Amplification Test Assay | 2012-04-30 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-12-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Great Basin Scientific, Inc. have?
Great Basin Scientific, Inc. has 4 FDA 510(k) clearances (first 2016, latest 2017), plus 1 De Novo decision, across 5 product codes in 1 review panel.
How long does FDA take to clear Great Basin Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Great Basin Scientific, Inc.'s cleared 510(k)s is 186 days.
What devices does Great Basin Scientific, Inc. make?
Its most frequent FDA product codes are OMN (C. Difficile Nucleic Acid Amplification Test Assay, 1); OZZ (Bordetella Pertussis Dna Assay System, 1); PAM (Gram-Positive Bacteria And Their Resistance Markers, 1).
Has Great Basin Scientific, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Great Basin Scientific, Inc; the most recent began 2016-12-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 4 Great Basin Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMN, Great Basin Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.