510(k) Report

FDA applicant

Hans J. Brouwers & Assoc.

Mount Prospect, IL2 decisions1985–19850 recalls

FDA records 2 decisions for Hans J. Brouwers & Assoc. (Mount Prospect, IL) in 1985: 2 510(k) clearances. Most are in product codes JPI (Device, Hematocrit Measuring) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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, hematology panel, where it files most

How often FDA has decided Hans J. Brouwers & Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hans J. Brouwers & Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hans J. Brouwers & Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Hans”

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