FDA applicant

Biotrine Corp.

Woburn, MA6 decisions1981–19920 recalls

FDA records 6 decisions for Biotrine Corp. (Woburn, MA) from 1981 to 1992: 6 510(k) clearances. Most are in product codes BZH (Meter, Peak Flow, Spirometry) and BZG (Spirometer, Diagnostic). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biotrine Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biotrine Corp.

Which product codes does it file in?

What has FDA decided for it lately?