510(k) Report

FDA applicant

Geneohm Sciences Canada, Inc.

Baldwin, MD2 decisions2006–20131 recall

FDA records 2 decisions for Geneohm Sciences Canada, Inc. (Baldwin, MD) from 2006 to 2013: 2 510(k) clearances. Most are in product codes NIJ (System, Test, Genotypic Detection, Resistant…) and NQX (System, Nucleic Acid Amplification Test, Dna…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Geneohm Sciences Canada, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species1decision
  • NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus…1decision

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 3 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.

  • K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 20132cite it
  • K061686Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 20061cites it

What has FDA decided for it lately?

  • K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 20131 recall
  • K061686Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006

All 2 as Geneohm Sciences Canada, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K133605Kit BD Max MRSA XT; Catalog # 443461Jul 17, 2019Class II

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. (Bd Life Sciences) 1