Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Great Basin Scientific, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | 2017-07-12 | 205 | 0 |
| K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017-03-31 | 60 | 0 |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | 2016-03-25 | 207 | 1 |
| K152955 | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | 2016-03-22 | 167 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda