FDA applicant

Fujirebio Diagnostics Texas, Inc.

Seguin, TX2 decisions2008–20080 recalls

FDA records 2 decisions for Fujirebio Diagnostics Texas, Inc. (Seguin, TX) in 2008: 2 510(k) clearances. All are in product code JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 3 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, clinical chemistry panel, where it files most

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

FDA decisions per year

2in 2008

2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Fujirebio Diagnostics Texas, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujirebio Diagnostics Texas, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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 America, Inc. 2 Fujirebio Europe N.V. 1 Fujirebio Dianostics, Inc. 1

Fujirebio Diagnostics Texas, 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”