FDA applicant

Biotron U.S.A., Inc.

West Chester, PA1 decision1990–19900 recalls

FDA records 1 decision for Biotron U.S.A., Inc. (West Chester, PA) in 1990: 1 510(k) clearance. All are in product code LBR (Ldl & Vldl Precipitation, Hdl). 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 Biotron U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotron U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biotron U.S.A., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biotron”

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

Biotron, Ltd. 5

Biotron U.S.A., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotron”