FDA applicant

Hematronix, Inc.

Benicia, CA9 decisions1990–20010 recalls

FDA records 9 decisions for Hematronix, Inc. (Benicia, CA) from 1990 to 2001: 9 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 2 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Hematronix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hematronix, 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?