510(k) Report

FDA applicant

SPD Development Company Limited

Bedford, Bedfordshire, GB1 decision2011–20110 recalls

FDA records 1 decision for SPD Development Company Limited (Bedford, Bedfordshire, GB) in 2011: 1 510(k) clearance. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 SPD Development Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — SPD Development Company Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

What has FDA decided for it lately?

  • K110433Clearblue Easy Pregnancy TestSPD Development Company Limited · 2011

The one decision as SPD Development Company Limited →