FDA applicant

Hamilton Thorne Research

Beverly, MA5 decisions1987–20020 recalls

FDA records 5 decisions for Hamilton Thorne Research (Beverly, MA) from 1987 to 2002: 5 510(k) clearances. Most are in product codes POV (Semen Analysis Device) and GKL (Counter, Cell, Automated (Particle Counter)). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 Hamilton Thorne Research’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hamilton Thorne Research since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hamilton Thorne Research’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Hamilton”

FDA records each applicant name separately; these may or may not be the same firm.

Hamilton Medical AG 45 Hamilton Co. 16 Hamilton Thorne, Inc. 6 Hamilton Industries, Inc. 5 Hamilton Thorne Biosciences 3 Hamilton Kent 1

Hamilton Thorne Research

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hamilton”