510(k) Report

FDA applicant

Diesse Diagnostica Senese S.P.A.

Hialeah, FL2 decisions2006–20070 recalls

FDA records 2 decisions for Diesse Diagnostica Senese S.P.A. (Hialeah, FL) from 2006 to 2007: 2 510(k) clearances. Most are in product codes LIO (Device, Specimen Collection) and LIP (Enzyme Linked Immunoabsorption Assay…). Its devices cite 2 predicates, 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, microbiology panel, where it files most

How often FDA has decided Diesse Diagnostica Senese S.P.A.’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 — Diesse Diagnostica Senese S.P.A. 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?

  • LIODevice, Specimen Collection1decision
  • LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K070062Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseDiesse Diagnostica Senese S.P.A. · 2007
  • K050590Enzy-Well Syphilis Igg, Model 91106Diesse Diagnostica Senese S.P.A. · 2006

All 2 as Diesse Diagnostica Senese S.P.A. →