510(k) Report

FDA applicant

Dynal Biotech, Inc.

Great Neck, NY1 decision1987–19870 recalls

FDA records 1 decision for Dynal Biotech, Inc. (Great Neck, NY) in 1987: 1 510(k) clearance. All are in product code JCF (Lymphocyte Separation Medium). 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 Dynal Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dynal Biotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JCFLymphocyte Separation Medium1decision

What has FDA decided for it lately?

  • K873185Dynabeads Hla Cell Prep II Isolation ProductDynal Biotech, Inc. · 1987

The one decision as Dynal Biotech, Inc. →