FDA applicant

Hyclone Laboratories, Inc.

Logan, UT11 decisions1987–19880 recalls

FDA records 11 decisions for Hyclone Laboratories, Inc. (Logan, UT) from 1987 to 1988: 11 510(k) clearances. Most are in product codes KIS (Sera, Animal And Human) and KIT (Media And Components, Synthetic Cell And…). 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 Hyclone Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hyclone Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hyclone Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?