FDA applicant

Gotham Biologics, Inc.

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Gotham Biologics, Inc. (Mchenry, IL) in 1980: 2 510(k) clearances. Most are in product codes KSF (Kit, Quality Control For Blood Banking Reagents) and KSG (Media, Potentiating For In Vitro Diagnostic Use). 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 Gotham Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gotham Biologics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gotham Biologics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?