FDA applicant

Dynagen, Inc.

Cambridge, MA6 decisions1992–19960 recalls

FDA records 6 decisions for Dynagen, Inc. (Cambridge, MA) from 1992 to 1996: 6 510(k) clearances. Most are in product codes JSY (Kit, Identification, Mycobacteria) and MIG (Strip, Test Isoniazid). 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 Dynagen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dynagen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Dynagen, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?