510(k) Report

FDA applicant

Biohit Plc

Neptune, NJ1 decision2004–20040 recalls

FDA records 1 decision for Biohit Plc (Neptune, NJ) in 2004: 1 510(k) clearance. All are in product code LYR (Helicobacter Pylori). Its devices cite 1 predicate, 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 Biohit Plc’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biohit Plc since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biohit Plc 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?

  • LYRHelicobacter Pylori1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K041238Helicobacter Pylori Igg ElisaBiohit Plc · 2004

The one decision as Biohit Plc →