510(k) Report

FDA applicant

Celera Diagnostics

Alameda, CA1 decision2007–20070 recalls

FDA records 1 decision for Celera Diagnostics (Alameda, CA) in 2007: 1 510(k) clearance. All are in product code NUA (System, Cystic Fibrosis Transmembrane…). 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, immunology panel, where it files most

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

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Celera Diagnostics 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?

  • NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062028Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics · 2007

The one decision as Celera Diagnostics →