Geneohm Sciences Canada, Inc. (Bd Diagnostics): FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Geneohm Sciences Canada, Inc. (Bd Diagnostics)” (first 2013, latest 2019), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 57 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 90 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Geneohm Sciences Canada, Inc. (Bd Diagnostics) took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 87 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | 1 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
Review panels
- Microbiology (4)
Most recent Geneohm Sciences Canada, Inc. (Bd Diagnostics) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191957 | BD MAX Vaginal Panel | PQA | 2019-10-21 | 90 |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | NQX | 2013-11-26 | 78 |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | OZN | 2013-04-02 | 36 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160001 | De Novo | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2016-10-28 |
Recalls
openFDA lists no recalls under a recalling firm named Geneohm Sciences Canada, Inc. (Bd Diagnostics).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Geneohm Sciences Canada, Inc. (2 510(k)s)
- Geneohm Sciences Canada, Inc. (Bd Life Sciences) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Geneohm Sciences Canada, Inc. (Bd Diagnostics)?
FDA lists 3 510(k) clearances under the applicant name “Geneohm Sciences Canada, Inc. (Bd Diagnostics)” (first 2013, latest 2019), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Geneohm Sciences Canada, Inc. (Bd Diagnostics)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geneohm Sciences Canada, Inc. (Bd Diagnostics) is 78 days.
Which FDA product codes appear under Geneohm Sciences Canada, Inc. (Bd Diagnostics)?
The most frequent FDA product codes under this applicant name are PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, 2); NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, 1); OZN (C. Difficile Toxin Gene Amplification Assay, 1).
Next steps
- See all 3 Geneohm Sciences Canada, Inc. (Bd Diagnostics) clearances with predicates and recalls
- Run predicate analysis for product code PQA, Geneohm Sciences Canada, Inc. (Bd Diagnostics)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.