Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Geneohm Sciences Canada, Inc. (Bd Diagnostics) — 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) |
|---|---|---|---|---|---|
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 | 90 | 0 |
| DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 | 291 | 0 |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 | 78 | 0 |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 | 36 | 2 |
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