FDA applicant

Wiener Laboratories Saic

Rosario, Santa Fe, AR24 decisions2001–20041 recall

FDA records 24 decisions for Wiener Laboratories Saic (Rosario, Santa Fe, AR) from 2001 to 2004: 24 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and JFJ (Catalytic Methods, Amylase). 1 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 Wiener Laboratories Saic’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wiener Laboratories Saic since 2007.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Wiener Laboratories Saic by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Wiener”

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

Wiener Laboratorios Saic 1 Wiener Laboratories 1

Wiener Laboratories Saic

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Wiener”