FDA applicant

Enzo Biochem, Inc.

New York, NY5 decisions1987–19880 recalls

FDA records 5 decisions for Enzo Biochem, Inc. (New York, NY) from 1987 to 1988: 5 510(k) clearances. Most are in product codes GQN (Antigen, Cf (Including Cf Control)…) and KHE (Reagent, Occult Blood). 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 Enzo Biochem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enzo Biochem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Enzo Biochem, Inc.

Which product codes does it file in?

What has FDA decided for it lately?