510(k) Report

FDA applicant

Ibl-Hamburg GmbH

Hamburg, DE2 decisions2005–20060 recalls

FDA records 2 decisions for Ibl-Hamburg GmbH (Hamburg, DE) from 2005 to 2006: 2 510(k) clearances. Most are in product codes CGR (Radioimmunoassay, Cortisol) and NST (Autoantibodies, Acetylcholine Receptor…). 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 Ibl-Hamburg GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ibl-Hamburg GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ibl-Hamburg GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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