FDA applicant

Gen Trak, Inc.

Plymouth Meeting, PA5 decisions1992–19920 recalls

FDA records 5 decisions for Gen Trak, Inc. (Plymouth Meeting, PA) in 1992: 5 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and LIZ (Assay, T Lymphocyte Surface Marker). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Gen Trak, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gen Trak, Inc.

Which product codes does it file in?

What has FDA decided for it lately?