FDA applicant

Wiener Laboratories

Rosario, Santa Fe, AR1 decision2003–20030 recalls

FDA records 1 decision for Wiener Laboratories (Rosario, Santa Fe, AR) in 2003: 1 510(k) clearance. All are in product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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 Wiener Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wiener Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wiener Laboratories 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 Laboratories Saic 24 Wiener Laboratorios Saic 1

Wiener Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Wiener”