510(k) Report

FDA applicant

American Laboratory Products Co., Ltd.

Windham, NH27 decisions1991–20020 recalls

FDA records 27 decisions for American Laboratory Products Co., Ltd. (Windham, NH) from 1991 to 2002: 27 510(k) clearances. Most are in product codes JZO (System, Test, Thyroid Autoantibody) and LJM (Antinuclear Antibody (Enzyme-Labeled)…). 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, immunology panel, where it files most

How often FDA has decided American Laboratory Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Laboratory Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Laboratory Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like American Laboratory Products Co., Ltd.’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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