510(k) Report

FDA applicant

Bd Diagnostics (Geneohm Sciences, Inc.)

San Diego, CA2 decisions2008–20096 recalls

FDA records 2 decisions for Bd Diagnostics (Geneohm Sciences, Inc.) (San Diego, CA) from 2008 to 2009: 2 510(k) clearances. Most are in product codes NQX (System, Nucleic Acid Amplification Test, Dna…) and LLH (Reagents, Clostridium Difficile Toxin). Its devices cite 4 predicates, 0 of them its own earlier devices. 6 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, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2013

2010: 12012: 42013: 1
2008high 4 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Bd Diagnostics (Geneohm Sciences, Inc.) by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bd Diagnostics (Geneohm Sciences, 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?

  • NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus…1decision
  • LLHReagents, Clostridium Difficile Toxin1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20085cite it
  • K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20092cite it

What has FDA decided for it lately?

  • K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20092 recalls
  • K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20084 recalls

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

What has been recalled?

6 recalls linked to its devices; the latest:

  • K081920BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200…Oct 11, 2013Class II
  • K093346BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm…May 22, 2012Class II
  • K093346BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm…May 22, 2012Class II
  • K081920BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm…May 22, 2012Class II
  • K081920BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD…May 22, 2012Class II
  • K081920BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD…Mar 5, 2010