FDA applicant

Biotrax, Inc.

Baltimore, MD4 decisions1990–19910 recalls

FDA records 4 decisions for Biotrax, Inc. (Baltimore, MD) from 1990 to 1991: 4 510(k) clearances. Most are in product codes GTQ (Antistreptolysin - Titer/Streptolysin O Reagent) and DCN (System, Test, C-Reactive Protein). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biotrax, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biotrax, Inc.

Which product codes does it file in?

What has FDA decided for it lately?