510(k) Report

FDA applicant

Eragen Biosciences

Madison, WI2 decisions2010–20110 recalls

FDA records 2 decisions for Eragen Biosciences (Madison, WI) from 2010 to 2011: 2 510(k) clearances. All are in product code OQO (Herpes Simplex Virus Nucleic Acid…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eragen Biosciences, Inc.”.

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 Eragen Biosciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Eragen Biosciences by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OQOHerpes Simplex Virus Nucleic Acid Amplification Assay2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K100336Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 20103cite it

What has FDA decided for it lately?

  • K111527Multicode-RTX Herpes Simplex Virus 1 & 2 KitEragen Biosciences, Inc. · 2011
  • K100336Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010

The one decision as Eragen Biosciences →The one decision as Eragen Biosciences, Inc. →