FDA applicant

Biotrol, USA, Inc.

Malvern, PA46 decisions1987–19950 recalls

FDA records 46 decisions for Biotrol, USA, Inc. (Malvern, PA) from 1987 to 1995: 46 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and 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 Biotrol, USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotrol, USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biotrol, USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?