510(k) Report

FDA applicant

Geneohm Sciences Canada, Inc. (Bd Life Sciences)

Quebec, CA1 decision2021–20210 recalls

FDA records 1 decision for Geneohm Sciences Canada, Inc. (Bd Life Sciences) (Quebec, CA) in 2021: 1 510(k) clearance. All are in product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Geneohm Sciences Canada, Inc. (Bd Life Sciences)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Geneohm Sciences Canada, Inc. (Bd Life Sciences) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Geneohm Sciences Canada, Inc. (Bd Life…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 20212cite it

What has FDA decided for it lately?

  • K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 2021

The one decision as Geneohm Sciences Canada, Inc. (Bd Life Sciences) →

Other applicant names beginning “Geneohm”

FDA records each applicant name separately; these may or may not be the same firm.

Geneohm Sciences Canada, Inc. (Bd Diagnostics) 4Geneohm Sciences Canada, Inc. 2