510(k) Report

FDA applicant

Bd Diagnostics (Geneohm Sciences Canada, Inc)

San Diego, CA2 decisions2007–20124 recalls

FDA records 2 decisions for Bd Diagnostics (Geneohm Sciences Canada, Inc) (San Diego, CA) from 2007 to 2012: 2 510(k) clearances. All are in product code NQX (System, Nucleic Acid Amplification Test, Dna…). Its devices cite 6 predicates, 0 of them its own earlier devices. 4 recalls are 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 Bd Diagnostics (Geneohm Sciences Canada, Inc)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2014: 12019: 12024: 12025: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus…2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 20075cite it
  • K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 20122cite it

What has FDA decided for it lately?

  • K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 20124 recalls
  • K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007

All 2 as Bd Diagnostics (Geneohm Sciences Canada, Inc) →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K111860BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX…Sep 23, 2025Class II
  • K120138BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916Oct 31, 2024Class II
  • K120138Kit BD Max MRSA; Catalog # 442953Jul 17, 2019Class II
  • K120138The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic…Jul 23, 2014Class II