510(k) Report

FDA applicant

Nanogen, Inc.

San Diego, CA2 decisions2006–20090 recalls

FDA records 2 decisions for Nanogen, Inc. (San Diego, CA) from 2006 to 2009: 2 510(k) clearances. Most are in product codes OLD (Internal Polymerase Chain Reaction Control…) and NBC (Test, Natriuretic Peptide). Its devices cite 1 predicate, 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, clinical chemistry panel, where it files most

How often FDA has decided Nanogen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nanogen, 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?

  • OLDInternal Polymerase Chain Reaction Control, Not Assay Specific1decision
  • NBCTest, Natriuretic Peptide1decision

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 1 time; 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.

  • K051596Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204Nanogen, Inc. · 20061cites it

What has FDA decided for it lately?

  • K083430Real-Time PCR Internal Control 2B SetNanogen, Inc. · 2009
  • K051596Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204Nanogen, Inc. · 2006

All 2 as Nanogen, Inc. →