510(k) Report

FDA applicant

Ams S.R.L. Analyzer Medical System

Guidonia, Rome, IT1 decision2008–20080 recalls

FDA records 1 decision for Ams S.R.L. Analyzer Medical System (Guidonia, Rome, IT) in 2008: 1 510(k) clearance. All are in product code CFR (Hexokinase, Glucose). 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 Ams S.R.L. Analyzer Medical System’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Ams S.R.L. Analyzer Medical System by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CFRHexokinase, Glucose1decision

What has FDA decided for it lately?

  • K080468Liasys with Models LiasysAms S.R.L. Analyzer Medical System · 2008

The one decision as Ams S.R.L. Analyzer Medical System →