510(k) Report

FDA applicant

Lehnus & Associates Consulting

East Stroudsburg, PA2 decisions2005–20110 recalls

FDA records 2 decisions for Lehnus & Associates Consulting (East Stroudsburg, PA) from 2005 to 2011: 2 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and CGR (Radioimmunoassay, Cortisol). 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 Lehnus & Associates Consulting’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lehnus & Associates Consulting by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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