FDA applicant

Fujirebio Dianostics, Inc.

Malvern, PA1 decision2019–20190 recalls

FDA records 1 decision for Fujirebio Dianostics, Inc. (Malvern, PA) in 2019: 1 510(k) clearance. All are in product code NIG (System, Test, Carbohydrate Antigen (Ca19-9)…). 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, immunology panel, where it files most

How often FDA has decided Fujirebio Dianostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Fujirebio Dianostics, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Fujirebio”

FDA records each applicant name separately; these may or may not be the same firm.

Fujirebio Diagnostics,Inc. 45 Fujirebio Diagnostics Texas, Inc. 2 Fujirebio America, Inc. 2 Fujirebio Europe N.V. 1

Fujirebio Dianostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fujirebio”